1,155 Jobs in Tralee

The Legal Counsel serves as the lead legal resource for Stryker's Global Quality and Operations Manufacturing Organization for the EMEA Region. The role is responsible for providing strategic legal leadership by providing accurate and timely legal advice to the manufacturing sites and to the functional areas on a broad range of matters across the EMEA Region.
**Essential Duties & Responsibilities:**
+ Provide strategic legal support to Stryker's manufacturing sites in EMEA Region.
+ Proactively work in building legal strategy.
+ Draft, edit, review, negotiate and advise on various types of contracts, including but not limited to master services agreement, equipment purchase agreement, development agreement, services, non-disclosure, and other agreements and proactively handling various manufacturing matters through to resolution.
+ Providing timely advice and counsel to clients.
+ Advising the business on laws, regulations and Stryker policies and procedures.
+ Developing and providing in-house training and education.
+ Following, implementing, developing and improving internal processes.
+ Collaborating and communicating with colleagues, senior management, and outside counsel.
+ Managing and strategizing with outside counsel.
+ Manage or assist in managing dispute resolution, including litigation and litigation strategy.
+ Work closely with Regulatory and Quality on regulatory matters, product complaints and recalls.
+ Partner with Business and Business Development Team on integrations of acquired business and products lines.
+ Support HR on employment matters and disputes.
+ Partner with Environmental Health and Safety Teams to provide counsel on EHS matters.
+ Partner with Compliance to provide counsel on compliance matters.
+ Support maintenance of legal entities and power of attorney.
+ Coordinate legal expenditures with Finance.
+ Work with other Legal Centers of Expertise on issues that arise to effectively support the business.
+ Address other requests for legal support and advice as required and appropriate.
**Education & Special Trainings:**
+ Law degree and admission to practice law in Ireland.
**Qualifications & Experience:**
+ Minimum of 10 years of related experience, to include in house, preferably as a member of a leadership team, and/or as part of a reputable law firm.
+ Experience in manufacturing and environmental, health and safety matters. Medical industry experience is valued.
+ Demonstrates strong judgment, professional demeanor and business acumen.
+ Demonstrates ability to work effectively with colleagues in a global organization.
+ Embraces and supports change in a dynamic environment.
+ Demonstrates ability to inspire, educate and empower others.
+ Reacts positively to changing needs and demands.
+ Ability to work well independently and in a team.
+ Possesses strong analytical and drafting skills.
+ Experience providing timely legal advice in a highly regulated environment preferred.
+ Demonstrates a commitment to high integrity and accountability.
+ Provides guidance and direction to others and demonstrates strong potential leadership skills.
+ Possesses strong communication skills and ability to convey complex legal principles clearly and concisely.
+ Has a general understanding of business financials and reporting.
+ Possesses strong organizational skills and is able to manage numerous projects and conflicting demands in a fast-paced environment.
+ Possesses strong interpersonal skills and ability to communicate at all levels of corporate organization.
+ Maintains confidential information.
+ Demonstrates proficiency in the Microsoft Office suite.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

JOB TITLE
Builder II, Product
REPORTS TO
Supervisor, Operations
POSITION SUMMARY
KEY AREAS OF RESPONSIBILITY
To effectively build the products manufactured by Stryker to the required quality standard.
? Responsible for manufacturing product in accordance with the relevant Stryker manufacturing procedures and relevant quality standards
? Participation in continuous improvement programmes or team projects to enhance our quality, customer service and cost
? Monitor and verify quality in accordance with workmanship standards and operating procedures.
? Adhere to procedures in relation to production methods, completion of documentation, current Good Manufacturing Practices and safety requirements
? Provide cross training to other employees
? Contribute as part of a team in achieving the line core metrics
? Build Quality into all aspects of their work by maintaining compliance to all quality requirements
? All other duties as assigned.
QUALIFICATIONS KNOWLEDGE SKILLS
? Minimum requirement is Leaving Certificate level or equivalent (or Junior Certificate with a number of years relevant work experience)
? Previous experience in production/ assembly roles is desirable
? Experience in the Health Care or Electronics industries is particularly relevant where precision placement and attention to detail is required.
? Good interpersonal skills.
? Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Demonstrate ability to effectively communicate with other employees and respond to questions
? Willingness to work in a team and promote teamwork.
? Ability to work flexible and/or extended hours and to rotate into different tasks and responsibilities.
? Ability to deal with situations with occasional variables.
? Ability to compare current situation to acceptance criteria
Job Description
? Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form
? Dexterity
? The employee may be required to use protective clothing and safety equipment such as safety glasses and respirators, and the use of personal protective equipment (PPE).
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**Sr Staff Microbiologist Role,** **Macroom, Cork**
**Hybrid - 3-4 days onsite**
**Your key responsibilities:**
+ Define local quality strategy to deliver safe, high-quality clean and sterile products while maintaining regulatory compliance
+ Oversight of Micro & Sterility key processes cleaning, cleanroom, sterilization and product testing
+ Coach, mentor, and drive awareness to other functions in area of Micro & Sterility
+ Subject matter expert to internal & external regulatory requirements (Corporate, FDA, ISO) and local procedure owner
+ Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.
+ Review and approval Cleaning / Cleanroom Equipment/ Process qualification/ validation / monitorings/ test reports
+ Timely communication, escalation, resolution of product issues causing supply chain disruptions
+ collaboration for cleaning/ sterilization/ environmental across sites in a global team across T&E Franchise
+ Continually identifies opportunity to drive efficiencies and margin improvements
+ Support compliance to Micro & Sterility standards in product transfers and new product introductions
**What are we looking for:**
+ Bachelor's degree/ Master of Microbiology or equivalent
and
+ Minimum of 6 years relevant experience
+ 2 years Microbiology related experience.
+ Experience in interacting with regulatory agencies (MDSAP, FDA, MoH, TUV, etc.) required.
+ Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)
+ Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
+ Strong interpersonal skills.
+ Strong written and oral communication and negotiations skills.
+ Strong in critical thinking and "outside the box" thinking.
+ Highly developed problem-solving skills.
+ Strong analytical skills.
+ Demonstrated ability to successfully manage and complete projects in a matrix organization.
+ Demonstrated ability to work independently.
+ Experience in working in a compliance risk situation.
+ High proficiency in statistical techniques, data review and analysis.
+ High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint packages.
#IJ
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**We're seeking a Senior Manager, Quality - Product Transfer to lead a high-performing team at the forefront of innovation in medical device manufacturing.**
In this hands-on leadership role, you'll play a pivotal part in our Product Transfer Quality team-mentoring engineers, guiding cross-functional collaboration, and ensuring every product transfer meets the highest standards of quality, safety, and regulatory compliance. Your work will directly shape the future of life-changing medical technologies
**What You Will Do:**
+ Sets direction: Drives the execution of Product Transfer strategy, with the goal of developing highly capable processes, that result in high yield and enable scalability.
+ Builds organizational capability: Promotes the optimization of inspection strategies for launch through technology, automation, and supplier certification. Enables the development of lean inspection strategies, enabling lower inspection cost per unit.
+ Inspires others: Coaching and development of staff who champion quality assurance during the product transfer process, ensuring product transfers meet or exceed established metrics.
+ Delivers results: Oversight and responsibility to ensure appropriate production and process controls are identified, qualified, and implemented throughout the manufacturing process.
+ Fosters collaborative internal/external professional relationships across Divisions and functions, associated with Product Transfer.
+ Collaborate with Regional QA Leaders to share and harmonize best practices, leverage lessons learned, and drive partnership and consistency within the global QA team.
+ Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful Product Transfers that meet the project goals as well as the regulatory requirements. ·
+ Oversight and responsibility to ensure adherence to product quality performance indicators (supplier DPM, right first time, manufacturing loss, manufacturing complaints per million, units recalled, product escapes and use-as-is), in conjunction with other targets. Continuously monitors to assess opportunities for improvement.
+ Guides the team to onboard suppliers with demonstrated quality, process capability and validation. Ensures robust supplier pFMEA, PPAP, supplier certification and inspection methods where appropriate.
+ Influences processes towards validation versus manual verification, where possible. · Drives competency in metrology within the quality assurance team including interpretation of complex engineering drawings and understanding of geometrical dimensioning and tolerance.
+ Ensures compliance to Stryker Corporate, GQO and external regulatory requirements.
+ Drive process development, optimization, and validation in a regulated medical device environment
+ Lead continuous improvement efforts and share best practices across global teams
**What You Need:**
+ Bachelor's Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage.
+ Minimum of 10+ years' experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
+ Minimum of 6+ years' experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team.
+ Experience in multiple areas / sites/ positions in the quality organization is advantageous.
+ Expert working knowledge of regulatory requirements, standards, and regulations, with experience of managing inspections/audits by the FDA and other bodies.
+ Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools.
+ Demonstrated leadership ability to develop and implement organization and functional strategy.
+ Initiates, sponsors, and implements change with a demonstrated track record.
+ Must be able to work in a team & individual environment, influencing effectively at all levels, and across all functions with ability to develop organizational relationship and build trust.
+ Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency always.
+ The candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**Position Summary**
Operating and setting up of CNC equipment including: Milling m/c's, Lathes, Screw-cutting machines and profile grinding equipment
**What you will do:**
+ Operating CNC Machines within a team environment, in line with standard operating procedures.
+ Reading and understanding of dimensions and tolerances on engineering drawings and hence determine machining requirements to successfully manufacture parts.
+ Setting up CNC machines, associated tooling and necessary material for the successful machining of components to engineering drawings.
+ Performing off-set adjustments to keep components within specification while still ensuring machine operates within validated parameters.
+ Trouble shooting of any machine issues and on the fly machine adjustments to maintain production output while still adhering to validated parameters.
+ Inspecting machined components by using precision measuring equipment to ensure components meet specifications.
+ Completing production records and maintenance logs.
+ Carrying out machine preventative maintenance.
+ Initiating process improvements to reduce setup times, cycle times and increase productivity, while positively impacting overall product cost.
+ Maintaining work station in line with the 6S standard of excellence.
+ Adhering to all Health and Safety procedures and requirements.
**What we are looking for:**
+ Must be DAT passed.
+ A technical background with experience operating machines.
+ Possess the ability to observe and correct minute inconsistencies.
+ Demonstrated ability to problem solve and show initiative in resolving machining issues.
+ Have ability to multi-task across a range of mechanical equipment.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

This role will be based in one of our **Cork sites.** Perform testing on medical device products and components using automated, semi-automated and manual methods. Follow test request protocols and report through mainly written but also verbally on the results of the tests. Evaluate variable data and understand and articulate attributes of product and component performance.
Throughout the placement, you will be an integral part of Stryker's **2026 Cooperative** cohort.
**Tasks and responsibilities may include:**
+ Together, with your Stryker team leader and college supervisor, **identify a process improvement project** along with project objectives, scope, success factors, milestones and evaluation metrics
+ Provide support to Research & Development, Advanced Operations and Global Quality Operations on the **development and verification testing** of new and existing products
+ Develop and coordinate **inspection and testing procedures** for prototypes, components and products
+ Formulate **test guidelines and procedures** and recommend revisions of specifications where necessary
+ Set up and perform **routine to non-routine experiments** of moderate scope which comply with FDA requirements and appropriate engineering standards
+ Extract and process **test data/findings** into **both formal written and verbal reports** which comply with FDA requirements and appropriate engineering standards
+ Assist in designing, installing and maintaining **process sampling systems, procedures, statistical techniques, testing mechanisms, equipment and fixtures**
+ Comply with **documentation procedures and maintain test laboratory** housekeeping standards to the highest level
+ Coordinate with facilities and assist in **the maintenance of test equipment** and **test lab fixtures and fittings**
+ Effectively adapts to practically working in a workplace by being **dependable, punctual, initiative-taking, hardworking, organised and a team-player**
**What we can offer:**
+ Attractive **salary** & **vacation** entitlement
+ Experience **our inclusive, people-first culture** . You will be paired with mentors and have access to leaders who **support your growth, give constructive feedback, and help build confidence.**
+ **Flexible** working hours
+ **Sports & Social** clubs and DE&I **Employee Resource Groups**
+ The opportunity to contribute to **real-world projects** that make a difference in improving **healthcare and patients' lives.** In Stryker, you will be given responsibilities that truly matter.
**What you will need:**
+ Currently completing an Irish or Northern Irish university qualification in Engineering courses including:
+ **Mechanical Engineering**
+ **Biomedical Engineering**
+ Have very good **visual acuity** and demonstrate fine motor skills, as well as observe and correct **minute inconsistencies** (e.g. in the printed word, product appearance, etc.)
+ Must be able to analyze and correct complex testing and/or systems issues of a broad scope using **independent judgment**
+ **Honesty and integrity;** must comply with the quality system, regulations, and company policies
+ **Self-motivated, flexible, and hardworking** - enjoys working in a dynamic, fast and results orientated environment
+ Is a **team player** and capable of working as part of a **multi-disciplined team**
+ Excellent verbal and written **communication skills** as well as a **basic level of PC skills**
+ A keen interest in all things **Engineering,** as well as an eagerness to **learn and develop**
+ Available for either **6, 9 or 12 months** - exact duration and start date to be discussed with your Talent Acquisition Business Partner at Stryker
**Next steps:**
+ Once you have applied to one of our co-op opportunities, our dedicated University Recruiting Business Partners will take some time to look through your application and ensure you meet the criteria in relation to the specific position.
+ Should all requirements be met, and you are happy to proceed, in September, successful candidates will be invited to a final round business interview with the hiring team.
+ If successful through the final round business interview, you will receive your offer shortly after
+ Please note, individual recruitment timelines may vary - please keep in contact with your University Recruiting Business Partner and your university placement coordinator for specific timelines and updates.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**Management Accountant**
**Permanent Contract**
**Model Farm Road.**
**Hybrid: 2-3 Days Per Week On-Site**
**What you will do:**
+ Calculate, reconcile, and analyze Inventory and Inventory-related Balance sheet and P&L items for period close; heavily utilizing advanced Excel techniques and Power Bi
+ Prepare month-end journal entries and formulate required accruals in accordance with GAAP
+ Ensure all Inventory reports generated are accurate, complete, and reconcile to the General Ledger, including the required IPE procedures.
+ As requested, perform ad-hoc analytical support, such as: analyzing inventory trends at various data levels, testing inventory reserve levels for appropriateness
+ Support business on implementation and monitoring of Internal Controls and other Compliance requirements.
+ Ensure all Company policies are followed completely and accurately.
+ Maintain up-to-date process documentation that incorporate changes in the business; may require updating or creating advanced Excel formulas and/or Power Bi workspaces or reports
+ Partner with business unit leaders at Model Farm Road facility regarding the ongoing development of their financial knowledge and the preparation of monthly financial outlooks.
+ Prepare commentaries and key ratio calculation for distribution to Leadership Team and divisional Finance personnel.
+ Drive process changes in the Finance area to ensure the provision of timely and relevant information to key business owners.
+ Work closely with Continuous Improvement team to assist in the completion of projects or assignments including process improvements and lean initiatives.
+ Support the annual budget and forecast process.
+ Support the standard cost roll.
+ Participate in internal and external audit process and liaise with auditors.
+ Actively contribute as part of the Finance Team to setting and achieving the team's goals and objectives.
+ Drive cost reduction culture in the site.
**Who we want?**
+ Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives and industry trends for sales, management and leadership teams.
+ Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change and outcomes.
+ Collaborative partners. People who build and leverage cross-functional relationships to bring ideas, data and insights to drive continuous improvements across the business.
+ Dedicated Achievers. People who thrive in a fast-paced environment and are driven to complete projects that meet regulations and expectations.
**What you need:**
+ Level 8 qualification or equivalent in Finance/ Accounting / Business
+ Part / Qualified Professional Accounting qualification.
+ 3+ years management accounting experience, from within industry and ideally a manufacturing environment.
+ Good knowledge of ERP systems and proficient use of MS Excel.
+ Be commercially aware and enjoy interacting with cross functional teams across a multi national organization.
+ Self-starter with demonstrated efficient work methods, analytical and problem solving skills and ability to handle multiple tasks in a fast paced environment
#IJ
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Job Title
**Sr. NPI Quality Engineer**
Reports To
**NPI QA Leader**
**Position Summary**
Executes design for manufacture and assembly through technical understanding of quality assurance, design control and preventative activities. Supports the development and introduction of new products, processes, and technologies, with focus on executing project deliverables with the guidance of senior engineering staff. Provide quality engineering support for the execution of quality assurance activities during design transfer phases of new product development. Provide Quality engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
**Position Requirements**
Will reside within the NPI QE team as part of GQO Quality Assurance organization and work collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities, including, but not limited to the following:
General
+ Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities.
+ Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
+ Mentor other groups and functions on areas of expertise with particular attention to design and process transfer.
Risk Management
+ Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).
+ Support the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release) through robust pFMEA.
+ Ensure all Risk Management outputs comply with ISO14971.
+ Support Design team to complete CQA/CTQ identification and inputs to dFMEA.
Inspection
+ Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable.
+ Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.
+ Lead First Article Inspection (FAI) Strategies, both internally and externally, and approve First Article Inspections. Optimize inspection costs through lean initiatives while maintaining safety, integrity, and reliability of the product.
+ Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.
Validation
+ Support the development, execution, and approval of validation protocols and reports.
+ Influence processes towards validation versus manual verification, where possible.
+ Support Sterilisation validation activity, as required.
Process Excellence
+ Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
+ Provide expertise for NC's & CAPA's related to new products.
+ Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development.
+ Support 'process bench marking' by providing quality experience as a process input.
+ Will promote human factor error prevention and provide expertise in the science of human factor error risk identification and mitigation.
Purchasing Controls
+ Support the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP).
+ Support the proper selection of suppliers.
+ Support implementation of supplier certification.
+ Support Supplier Quality to establish Quality Agreements with Stryker sites and suppliers as part of NPI projects.
Design Transfer
+ Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, under the guidance of Senior NPI QE engineers.
+ Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.
+ Support device design into production specifications.
+ Lead the efficient and timely transfer of lessons learnt knowledge to Quality engineering support, and global peers.
+ Provide expert quality process support post launch per DTAP agreement.
+ Support the control of product, through appropriate system containment to guard against product escape during pre-released builds.
**Qualification Knowledge Skills**
+ B.S in Engineering or related subject with 2 or more years' experience
or
+ Previous experience in a regulated environment within a manufacturing environment desirable. 2 years' experience in new product/process is a distinct advantage.
Note: Local qualifications may differ and will take precedence over the above criteria
+ Previous experience in a regulated environment within a manufacturing environment required. 2 years' experience in new product/process is a distinct advantage.
+ CQE or equivalent course work / experience desirable
+ Familiarity with advanced product quality planning framework and techniques used to develop products, a distinct advantage.
+ Proficient in understanding of Med Device manufacturing processes desirable.
+ Familiarity with ISO 13485, QSR, GDP, GMP desirable.
+ Lean Six Sigma training a distinct advantage.
+ Highly proficient in all aspects of Validation. Computer System validation a distinct advantage.
+ Excellent analytical skills, ability to plan, organize and implement concurrent tasks.
+ Competency in Metrology including ability to interpret complex engineering drawings and understand geometrical dimensioning and tolerance.
+ Must be able to generate, follow and explain detailed operating procedures
+ Understanding of complex problem-solving and process improvement techniques related to design/process/technical issues using lean six sigma tools like DMAIC.
+ Ability to manage several projects at once.
+ Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.
+ Basic knowledge/experience of risk based and statistical techniques, in particular process risk, failure mode and effect analysis (FMEA), statistical sampling plans, process capability and MSA's.
+ Manages change well and adopts a continuous improvement mindset
+ Excellent English (both oral and written)
+ Ability to be the voice of quality when dealing cross functionally
**___**
**Employee Signature: Date:**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**Change Management Specialist (CAII)**
**Contract:** 18 Month Contract
**Hybrid Position:** Initially 3-4 days On-Site, and approx. 1-2 Days afterwards
**Location:** Supporting both Limerick & Tullagreen, Carrigtwohill Site. Preference would be Limerick based however, open to either.
The Change Control Analyst will provide technical leadership and direction in changes. Responsible for the oversight & assessment of changes to the quality management system. Will oversee and ensure that changes to quality management system processes and procedures are compliant, effective and pose no risk to the quality of the product/processes. Will work within the QMS team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following:
**Main Responsibilities:**
+ Execute and/or Participate in the Change Control review forums and in multi-site forums.
+ Lead, facilitate, and mentor teams through all stages of the change control process.
+ Interface between functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes.
+ Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriateness
+ Liaise with Change Requester and SMEs during all stages of the Change Control process.
+ Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight.
+ Monitoring completion of post release tasks to ensure completion in a timely manner.
+ Support and lead initiatives for continuous improvement.
+ Participate in cross-plant and corporate project teams in areas of change control.
+ Manage Change Control KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums.
+ Support in training needs related to the change control process
+ Support in the preparation, participate and follow up to Stryker Internal, Corporate and third-party compliance audits.
**Experience & Skills Required:**
+ Level 8 qualification or equivalent in Engineering, Science or relevant field
+ Previous experience in the medical device industry desirable
+ Understanding of Med Device concepts desirable.
+ Familiarity with ISO 13485, GDP, GMP concept desirable.
+ Excellent communication skills and attention to detail.
+ Knowledge of ERP Change Control Systems.
+ Experience working cross-functionally across projects
+ Have a good understanding of engineering and quality concepts / theories.
+ High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
+ Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
+ Must be willing to work as part of a multi-site team, with some travel required.
+ Knowledge of Risk Based and statistical concepts desirable.
+ Problem solving and analytical skills.
+ Builds strong relationships by fostering open communications, respect and trust
#IJ
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.