Principal Quality Engineer

3 weeks ago

Los Angeles, California, United States Medtronic Full time
About the Role

We are seeking a highly skilled Principal Quality Engineer to join our team at Medtronic. As a key member of our quality team, you will be responsible for supporting the CAPA process, change control, and internal/external audit support activities for the Medtronic Diabetes business.

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.
  • 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.
  • As needed, assist team in developing solutions to problems via effective means of root cause analysis, and offer possible improvements to processes and systems.
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.
  • Nice to Have: 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 reviewing technical documentation.
  • Strong written and verbal communication skills.
  • Strong critical thinking and analytical skills.
What We Offer

Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees' lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD): $116, $174,000.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

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