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Principal Quality Engineer-CAPA and Quality System
| Company | Medtronic |
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| Location | Los Angeles, CA, USA |
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| Salary | $116000 – $174000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Senior, Expert or higher |
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Requirements
- 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
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.
- Support DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained.
- 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.
- Assist team in developing solutions to problems via effective means of root cause analysis, and offer possible improvements to processes and systems.
- Leverage analytical tools to deliver solutions that help solve business problems (Power BI, Power Apps, SharePoint Online, Excel, etc.).
- Deliver ongoing reporting & analytics of KPIs to the SR Leadership Team and for CAPA Board meetings.
Preferred Qualifications
- 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.
- Previous experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques.
- Experience with quality tools and process improvement techniques.
- Experience reviewing technical documentation.
- Strong written and verbal communication skills.
- Strong critical thinking and analytical skills.
