Principal Quality Engineer
4 days ago
We are seeking a highly skilled Principal Quality Engineer to join our team at Medtronic. As a key member of our Diabetes business, you will be responsible for supporting the CAPA process, change control, and internal/external audit support activities.
Key Responsibilities- Create and revise standard operating procedures, as needed.
- Perform ongoing gap analysis against requirements and regulations to include routing and release of documentation in Agile and working with managers to assign employee training.
- Ensure local team is following procedures and the QMS is operating effectively.
- Update and/or manage Quality Metrics.
- Assist with Management Review and CAPA Board meeting preparations.
- Function as the site key compliance contact.
- Assist in preparations for internal and external audits.
- Lead or participate in audits, as needed.
- Support external regulatory audits as needed.
- Evaluate, trend and triage issues that may be considered CAPAs.
- Communicate effectively and ask the right questions of team members while presenting issues, trends and feedback clearly at CAPA Board Meetings.
- Actively track CAPA's, as needed, and remain diligent to ensure the tasks are completed on time.
- Bachelor's Degree and 7+ years of Quality Engineering and/or regulated industry experience.
- OR Advanced Degree and 5+ years' experience Quality Engineering and/or regulated industry experience.
- 10+ years' Management Review, Change Control and Audit processes.
- Experience with TrackWise software.
- Working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc.
We are a global leader in healthcare technology and boldly attack the most challenging health problems facing humanity. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.
We have the talent, diverse perspectives, and guts to engineer the extraordinary.
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