Senior Quality Engineer
Job in
Chaska, Carver County, Minnesota, 55318, USA
Listed on 2026-07-13
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-13
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Responsibilities
- 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
- 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
Position Requirements
10+ Years
work experience
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