Principal Quality Engineer
Medtronic
full-time
Posted on:
Location Type: Office
Location: Mounds View • Colorado, Connecticut, Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $119,200 - $178,800 per year
Job Level
SeniorLead
About the role
- Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards.
- Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle.
- Conduct risk assessments and manage risk mitigation activities in accordance with ISO 14971 and other applicable standards.
- Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections.
- Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements.
- Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports.
Requirements
- Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality assurance processesrisk assessmentsrisk mitigationvalidation activitiesverification activitiestest plansprotocolscompliance reportsdocumentationISO 14971
Soft skills
leadershipmentoringcollaborationcommunication