Senior Quality Engineer

Job DutiesSenior Quality Engineer for Monteris Medical Corporation dba Monteris Medical. Lead cross-functional improvement efforts in support of the product and Quality System. Lead CAPA (root cause analysis, corrective and preventive action planning, solution development, execution, and verification). Resolves first level manufacturing and technical issues in a timely manner via NCR process. Performs product inspection, testing, and final release authorization. Review completed production orders and shipments for completion/accuracy. Review field service records and maintain capital equipment DHR. Assists with returns decontamination, complaint investigation/analysis and final release of sterile products including collaboration with contract manufacturers as applicable. Assists with equipment and facilities qualification, calibration and maintenance. Assists with Product Surveillance and Risk Management activities including FMEA development. Performs process validation planning and execution, revalidation assessments. Implements and trends manufacturing and quality system indicators (e.g. SPC, scrap trending, etc.). Support line transfers. Controlled Environment Validation, Maintenance, and Monitoring. Ability to support external and internal audits. Provide mentorship/guidance to junior engineers.Role is located in Minnetonka, Minnesota and requires on-site presence to provide direct support to production.Minimum Education RequiredMaster’s degree in Engineering Management, Biomedical Engineering, Electrical Engineering or Mechanical Engineering and two (2) years of experience as a quality engineer in medical device manufacturing with specific experience in Class 2/3 devices OR Bachelor’s degree in Engineering Management, Biomedical Engineering, Electrical Engineering or Mechanical Engineering and five (5) years of experience as a quality engineer in medical device manufacturing with specific experience in Class 2/3 devices.Minimum Experience RequiredMaster’s degree in Engineering Management, Biomedical Engineering, Electrical Engineering or Mechanical Engineering and two (2) years of experience as a quality engineer in medical device manufacturing with specific experience in Class 2/3 devices OR Bachelor’s degree in Engineering Management, Biomedical Engineering, Electrical Engineering or Mechanical Engineering and five (5) years of experience as a quality engineer in medical device manufacturing with specific experience in Class 2/3 devices. Must possess at least 2 years of experience with the following:• Documentation and technical writing skills.• Software packages in presentations, data processing, engineering reports and Microsoft project.• Root cause analysis, electrical and mechanical problem solving.• Complaint handling, post market surveillance, risk assessment, test method development, and process validation.• Lean principles and Statistical Process Control experience.The following Certification is required:• ISO 13485 Lead Auditor Certified.ShiftFirst (Day)Number of Openings1Compensation$143,062.00Postal Code55305Place of WorkOn-siteRequisition ID5432Job TypeFull TimeJob BenefitsStandard Benefits.Application InstructionsFor confidential consideration, please submit resume via email: . No agencies or phone calls please.

Created: 2026-03-04