Senior Quality Engineer

IMRIS

Senior 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

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

engineeringquality assurancecompliance analysisSOP authoringdesign history file auditsrisk managementtechnical drawing interpretationFDA inspectionsMDSAP auditsISO 13485

Soft Skills

cross-functional teamworkcommunicationleadership advisingorganizational skillsanalytical skills