Quality Systems Engineer (m/f/x) (New Health Care Company)

Full Job Description

3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter.

Job Description:

Job Title - Quality Systems Engineer (New Health Care Company)

3M is establishing two  industry-leading companies, creating value through the spin- off of its Health Care business, while 3M will continue to be a global material science leader, focusing our innovation to win in favorable global megatrends and attractive end markets. This new Health Care Company will be a leading global diversified health technology company with:      

• Proven category leadership   

• Exposure to attractive end-markets   

• Innovation mindset driving improved patient outcomes   

• Collaborative customer relationships   

• Deep global regulatory experience   

• Operational excellence and strong cash flow   

• Strong sales growth and profitability with significant recurring sales   

We expect the creation of the two companies will be completed by the end of Q1 2024. For now, we will continue to operate as one global company. This role is positioned to drive the success of the "New Health Care Company”.   

The impact you have in this role

As Quality Systems Engineer, you will have the opportunity to put your curiosity to good use and collaborate with some of the most innovative and diverse people in the world. Here's how to make an impact:

• Representing Quality function in Site Management meetings as required.

• Acting as a delegate for the Quality Lead.

• Leading and implementing significant process improvements, projects and cost saving initiatives using data & quality tools to drive quality decisions. Initiating project plans, identifying resource allocations, performing and guiding technical activities such as risk documentation, procedural updates, test methods, process / software validation that have major importance to the business.

• Initiating, reviewing, approving, and providing guidance on change controls and change control process.

• Performing, analysing and interpreting statistical data using a detailed understanding of statistical tools and methods.

• Leading investigations and providing technical guidance to peers in relation to CAPAs and NC and to address compliance issues and providing guidance to engineering.  Leading the implementation of robust solutions. 

• Ensuring QMS is implemented and adhered to by completing independent assessment of QMS documentation as required. Independently assess and provide guidance to Quality and Engineering disciplines.

• Provide periodic training for company personnel on the company’s Quality System processes and procedures.

• Performing and leading Internal and Supplier Audits.

• Facilitating and participating in external regulatory body audits, e.g. ISO and FDA

• Implementing Key Performance Indicators within the Quality Assurance area to align with site and global quality objectives.

• Complete data analysis for Management Review.

• Co-ordinate collection of data for PMS.

• Actively lead QMS Process Improvement Projects

• Complying with all relevant training required and adhere to relevant associated documentation.

• Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.

• Following strict adherence to the requirements of CGMP.

• Ensuring compliance to quality systems and all applicable regulations/standards, and internal procedures.

Your Skills and Expertise 

To set you up for success in this role from day one, 3M is looking for candidates who must have the following qualifications:

• Degree in Engineering or Science related field (minimum level 8)

• Lead Auditor or Internal Auditor certification an advantage.

• Five (5) years’ experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments is preferable.

• Strong computer skills (MS Excel, PowerPoint, Word etc.)

• Strong knowledge of statistical tools and techniques

• Strong knowledge of FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.

• Strong knowledge of problem solving techniques.

• Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.

• Knowledge of the Quality System Regulation and associated regulations and standards.

• Attention to detail and accuracy is essential.

• Experience with front and back room is strongly preferred.

• Strong analytical reasoning and ability to work well under deadlines and pressure is essential.

Additional qualifications that could help you succeed even further in this role include:

• Excellent organizational and project management skills, ability to effectively manage multiple projects. Attention to detail and accuracy is essential.

Supporting Your Well-being

3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.

Resources for You

For more details on what happens before, during and after the interview process, check out the Insights for Candidates page at 3M.com/careers. If you have further questions please reach out to Max (our AI Virtual Assistant) via our Career Page. 

• Location Information (Athlone, Ireland)

• Work Your Way - Hybrid eligible

• €high-reaching dependent on skills and experience plus excellent benefits package

Supporting Your Well-being  

3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope. 

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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