5 IT Devices jobs in Ireland

Quality Engineer- Medical Devices

Athlone, Leinster Total Talent Solutions

Posted 2 days ago

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Job Description

We are recruiting on behalf of a global medical device leader for a talented Quality Engineer to join their team on a 12-month contract. This role is perfect for an experienced quality professional who wants to expand their skills, work on high-profile projects, and gain exposure in a regulated environment without committing to a permanent role. What You'll Be Doing Lead quality improvement initiatives to enhance processes, reduce costs, and ensure regulatory compliance. Support change controls, risk assessments, and process validations. Analyse data and spot trends using statistical tools. Write and review CAPAs, non-conformance reports, and supplier corrective actions. Conduct audits and support inspections by ISO and FDA regulators. Collaborate across teams to embed best practices in quality standards. What You'll Need 3+ years' experience in a regulated environment - ideally medical devices or FDA/ISO 13485 certified manufacturing. Degree in Quality, Science, or Engineering. Strong MS Excel, Word, and PowerPoint skills. Experience with FMEAs, root cause analysis, and statistical analysis. Excellent attention to detail and problem-solving ability. Skills: Quality Manager Communication CAPA
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Quality Engineer I – Medical Devices

Cork, Munster Pale Blue Dot® Recruitment

Posted today

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full-time permanent

Location: Galway (On-site)
Industry: Medical Device / Start-up
Our client, a dynamic and fast-paced medical device start-up based in Galway, is seeking a Quality Engineer I to join their growing team. The company is focused on developing innovative, patient-centric technologies to improve quality of life and is advancing rapidly through the product development lifecycle toward global market launch.

This role offers a unique opportunity for a motivated and hands-on quality professional to apply their engineering knowledge across multiple areas of a developing Quality Management System. The ideal candidate will enjoy working in a cross-functional, start-up environment and contributing directly to impactful product development.

Responsibilities include but are not limited to the following:

  • Apply quality engineering expertise across the Quality Management System (QMS).

  • Support certification and maintenance of compliance to ISO 13485 and 21 CFR Part 820.

  • Assist with design assurance activities, including design controls, verification, and validation.

  • Support development and validation of test methods and computer system assurance programs.

  • Participate in risk management and usability engineering activities.

  • Maintain document control through QT9 eQMS and perform related administrative tasks.

  • Contribute to the CAPA and non-conformance (NC) investigation and resolution process.

  • Assist in internal and external audits and implement corrective actions as needed.

  • Support updates and gap assessments for applicable regulatory standards and guidance.

  • Participate in supplier quality management, vendor evaluation, and AVL maintenance.

  • Collaborate cross-functionally to uphold quality objectives and continuous improvement.

  • Perform additional quality-related duties to support business goals and KPIs.

  • Bachelor’s degree in engineering, science, or related field (or equivalent).

  • Minimum of 2 years' experience in a medical device or supplier environment.

  • Familiarity with ISO 13485, FDA QSR (21 CFR Part 820), and GMP requirements.

  • Experience in both FDA and European regulatory environments is preferred.

  • Strong initiative, problem-solving, and follow-through in executing responsibilities.

  • Understanding of risk management methodologies (ISO 14971).

  • Experience with sterilization (EtO/Gamma), biocompatibility, and transportation testing is a plus.

  • Prior involvement in audits or inspections is an advantage.

  • Proficiency in MS Office and familiarity with electronic QMS tools.

Immediate interviews available for suitable candidates.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other future vacancies

 Pale Blue Dot® Recruitment

The Experts in STEM Workforce Solutions

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Medical Devices Global Regulatory Documentation Manager

Sligo, Connacht Abbott

Posted 1 day ago

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Job Description

**FIXED TERM CONTRACT**
**Abbott in Ireland**
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Nutrition**
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.
**PURPOSE OF THE JOB**
As a Medical Safety & Surveillance (MSS) Global Medical Device Manager, the candidate will use his/her in-depth understanding of medical devices to ensure compliance with regulatory requirements for Abbott Nutrition medical devices. The MSS Global Medical Device Manager will have responsibility for generating documentation that supports Abbott Nutrition's global medical device registration and on-going compliance with EUMDR. This may include development and implementation of global standardized operating procedures. The candidate may also lead the development/maintenance of local medical device vigilance systems (predominantly for UK and EU), ensuring compliance with local regulations. The candidate will have departmental, cross functional, and global influence, and will be considered a medical device subject matter expert within the company.
**MAJOR RESPONSIBILITIES**
+ Organizes, manages and maintains a highly compliant global medical device system for Abbott Nutrition.
+ Maintains awareness and ensures compliance with established and updated local and global medical device processes as well as local and global regulations and guidelines for medical device registration and post-market documentation.
+ Develops and implements training programs for individuals involved in medical device activities.
+ Monitors medical device system performance; tracks compliance metrics and reports to global MSS Leadership Team.
+ Ensures global/local medical device audit readiness; Supports medical device audits/inspections and leads activities related to corrective and preventative actions for any audit findings.
+ Actively contributes to activities related to the monitoring of safety profiles for Abbott Nutrition products registered as medical devices, such as signal detection, evaluation, and prioritization.
+ Reviews and provides input to product DFMEAs.
+ Assists local staff with drafting and implementation of Safety Data Exchange Agreements, if applicable.
+ Works cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures.
+ Assists in the preparation, review and submission of aggregate safety reports.
+ Accountable for strategic preparation of medical device regulatory submission documentation (i.e. CEP, CER, PSUR, PMCF etc) and on-time completion of these activities for the division.
**EDUCATION & COMPETENCIES**
+ Master's degree in related health science or equivalent skills, education, or experience.
+ RAC certification is a plus.
+ 5-7 years of experience and proficiency in medical device regulatory submissions to Notified Bodies under EUMDR / MedDEV and knowledge of Medical Device standards and guidelines (such as ISO, GSPR, and MDGC).
+ Solid understanding and working knowledge of medical device regulatory requirements and in the development and implementation of processes to maintain compliance.
+ Strong medical knowledge and understanding to support safety related activities; background/experience with nutrition/nutritional products is a plus.
+ Knowledge of Vigilance reporting regulations on a Global scale.
+ Minimum 3 years of experience in leading complex projects or programs; global/regional experience desirable.
+ Fluency in spoken/written English;
+ Computer proficient (Windows, Word, Excel); experience working in adverse event databases.
+ Excellent communication and interpersonal skills, both written and spoken.
+ Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects.
+ Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity.
+ High level of accountability and reliability.
+ Demonstrates ability to work productively as a team.
+ Ability to work in a fast paced, changing environment.
+ Ease of operating in high stress, big decision situations.
+ Continuous improvement mindset.
+ Ability to influence a team in a positive way in relation to performance, change, and culture.
+ Demonstrate broad knowledge of Abbott's business and how department processes/responsibilities interconnect.
+ Mastery of the inventory deployment planning process.
+ Exceptional problem-solving skills
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
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Tooling & Equipment Design Engineer – Medical Devices

H91K2K0 Tipperary, Munster Pale Blue Dot® Recruitment

Posted 1 day ago

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Job Description

contract

Location: County Tipperary (On-site)
Contract: 12-Month Fixed Term (with potential for extension)

Our client, a well-established engineering firm, is seeking a Tooling & Equipment Design Engineer to support the development of custom tooling and mechanical systems for implantable medical devices. The role is based on-site at a world-class manufacturing facility in County Tipperary. This is a hands-on, technically challenging role ideal for an experienced mechanical engineer who enjoys precision design, collaboration, and seeing their work make a real-world impact.

Responsibilities include but are not limited to:

  • Design and develop mechanical tooling, fixtures, and assembly equipment to support advanced medical device manufacturing.

  • Create detailed 3D models and engineering drawings using CAD (preferably SolidWorks).

  • Collaborate with manufacturing, quality, and product development teams to ensure seamless integration of new equipment and processes.

  • Participate in design reviews, technical problem-solving, and continuous improvement initiatives.

  • Liaise with external vendors, suppliers, and equipment manufacturers to ensure quality and timely delivery of components.

  • Support the validation and qualification of new equipment and processes as required.



  • 3+ years of mechanical design experience, ideally in tooling, fixtures, or automation within a medical device or regulated manufacturing environment.

  • Strong proficiency in CAD (SolidWorks preferred).

  • Solid understanding of mechanical engineering principles, materials, and production techniques.

  • Proven ability to deliver detailed and accurate mechanical designs within project timelines.

  • Excellent problem-solving skills and attention to detail.

  • Strong communication and teamwork skills.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

 Pale Blue Dot® Recruitment

The Experts in STEM Workforce Solutions

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Clinical Nurse Manager II - Cardiac Devices

Dublin, Leinster recruitNet

Posted 362 days ago

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Job Description

Permanent
RecruitNet International Ltd   Specializing in relocating qualified professionals throughout Ireland and overseas,We are hiring a Clinical Nurse Manager II - Cardiac Devices  to a leading private hospital in Dublin, Ireland. We will provide exceptional patient care in an environment where quality, respect, caring, and compassion are at the center of all we do. Responsibilities Providing patients with cardiac devices with outstanding patient care. Serving as an exemplar for the nursing team, you will advocate for optimal procedures and offer proficient clinical assistance to the interdisciplinary group. Patients wearing cardiac devices should receive specialized treatment. Serve as an inspiration and a defender of cardiac device nursing best practices. Work well together as a multidisciplinary team to provide patients with seamless care. RequirementsA general registered nurse with at least five years of experience. Two years or more of experience as a cardiovascular nurse specialist.Excellent interpersonal and leadership skills.A willingness to seek a degree, a recognized certificate at a higher diploma level or equivalent, and a dedication to ongoing professional growth. A solid grasp of the fundamentals of nurse education and development. BenefitsThis is a fascinating opportunity to join a growing vibrant private hospital that, due to its structure, focuses completely on patient care and has the resources to do so.We promote a strong team ethic, a holistic approach to nursing, and foremost excellent patient care.We support and develop our nurses and facilitate ongoing training and development.
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