Principal Quality Engineer - Post Market Risk
$119.2k/y-$178.8k/y
4 days ago
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OnsiteFull-timeSenior
Summary
Medtronic is seeking a Principal Quality Engineer - Post Market Risk to join their team in North Haven, CT. The role involves leading risk management efforts for robotic surgical technologies and ensuring compliance with quality standards.
About the Role
As a Principal Quality Engineer, you will serve as a Subject Matter Expert for Risk Management across the Post-Market space, accountable for maintaining Risk Management Files and conducting product Risk Analysis in compliance with ISO14971. You will evaluate product risks against field data, manage Product Hold Orders, and drive Post-Market Issue Evaluations. Additionally, you will support regulatory engagements and collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle.
About You
Required:
- Bachelor's degree with a minimum of 7 years of relevant experience, or a Master's degree with 5 years of relevant experience, or a PhD with 3 years of relevant experience.
- Strong knowledge of risk management principles and quality assurance processes.
Preferred:
- Experience in medical device manufacturing and regulatory compliance.
- Familiarity with ISO14971 and other relevant quality standards.
Benefits
- Competitive salary range of $119k–$179k.
- Flexible benefits package including health, dental, and vision insurance.
- 401(k) plan with employer contribution and match.
- Paid time off and holidays.
- Tuition assistance and reimbursement.
Medtronic
A global healthcare technology leader — boldly attacking the most challenging health problems facing humanity with innovations that transform lives.
North Haven, CT