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Senior Quality Engineer
IMRISSenior Quality Engineer at IMRIS responsible for post-release product compliance and quality assurance in medical devices. Working within a cross-functional team to support product development and audits.
Posted 6/23/2026full-timeChaska • Minnesota • 🇺🇸 United StatesSenior💰 $120,000 - $130,000 per yearWebsite
ATS Keywords
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Hard Skills
engineeringquality assurancecompliance analysisSOP authoringdesign history file auditsrisk managementtechnical drawing interpretationFDA inspectionsMDSAP auditsISO 13485
Soft Skills
cross-functional teamworkcommunicationleadership advisingorganizational skillsanalytical skills
Industry Keywords
medical device standardsChange OrdersNonconformance ReportsCorrective and Preventive ActionsISO 14971ISO 62304Medical Electrical Equipment Safety Standardspre/post market regulationsaudits and inspectionsquality standards
About the role
Key responsibilities & impact- Analyze medical device products for compliance to standards
- Participate in the Design Change process
- Author new SOPs and other documentation
- Review and approve Change Orders (COs), Nonconformance Report (NCRs), Corrective and Preventive Action (CAPA) records
- Work within a cross-functional team to support product development
- Perform Design History File audits
- Provide compliance guidance concerning development, application, and maintenance of quality standards
- Prepare, support, and ensure readiness for audits and inspections
Requirements
What you’ll need- Bachelor of Science (B.S.) degree or higher in engineering
- At least 5 years of experience in engineering or Quality
- Direct experience with FDA inspections, MDSAP audits, ISO 13485 audits
- Experience advising senior leadership and applying pre/post market regulations
- Knowledge of ISO 14971 Risk Management standard
- Knowledge of ISO 62304 Life Cycle Requirements for Medical Device Software
- Knowledge of Medical Electrical Equipment Safety Standards
- Ability to read, analyze and interpret engineering/technical drawings
Benefits
Comp & perks- Health insurance
- Dental insurance
- 401(k) Savings Plan plus matching
- Flexible Spending Account
- Life Insurance
- Disability Insurance
- Vision Insurance
- Generous paid time off and sick leave
- Incentive Bonus
- Paid Parental Leave