Senior Quality Engineer - Injection Molding | Medical Devices
Listed on 2026-10-05
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Quality Assurance - QA/QC
Quality Engineering, Production QC/QA, Regulatory Compliance Specialist
Compensation: $91,000 - $130,000 annually
Experience: 6+ years
We are seeking an experienced Senior Quality Engineer to support manufacturing quality within a precision medical-device manufacturing environment.
This is a hands-on quality engineering role supporting production, process improvement, validation, inspection, corrective actions, and quality systems. Candidates with experience in injection molding, medical-device manufacturing, precision manufacturing, or other highly regulated manufacturing environments will be particularly relevant.
Key ResponsibilitiesLocation: Brooklyn Park, MN
Work Arrangement: On-site
Compensation: $91,000 - $130,000 annually
Experience: 6+ years
Relocation Assistance: Not available
Visa Sponsorship: Not available
We are seeking an experienced Senior Quality Engineer to support manufacturing quality within a precision medical-device manufacturing environment.
This is a hands-on quality engineering role supporting production, process improvement, validation, inspection, corrective actions, and quality systems. Candidates with experience in injection molding, medical-device manufacturing, precision manufacturing, or other highly regulated manufacturing environments will be particularly relevant.
Key Responsibilities- Provide quality engineering support to manufacturing and cross-functional project teams.
- Develop and maintain inspection plans, control plans, quality documentation, and manufacturing quality requirements.
- Facilitate and support PFMEA activities and manufacturing risk assessments.
- Investigate nonconforming or discrepant material and drive appropriate corrective and preventive actions.
- Support customer complaint investigations through failure analysis, root-cause analysis, CAPA, and trend analysis.
- Analyze manufacturing and quality data to identify process-improvement opportunities.
- Support process, equipment, and metrology validation activities.
- Develop validation protocols and analyze validation and manufacturing data.
- Perform and support internal and external quality audits and ensure closure of audit findings.
- Provide technical guidance related to inspection methodologies, measurement systems, and quality requirements.
- Support Quality Inspectors in ensuring inspection plans meet product and customer requirements.
- Apply statistical quality techniques including DOE, process capability studies, SPC, and data analysis
. - Support implementation and maintenance of quality-management and business systems.
- Partner with Manufacturing, Engineering, Operations, Customer Service, Sales, and other functions.
- Mentor and provide technical guidance to less-experienced quality engineers when required.
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or another relevant engineering discipline
. - Minimum 6 years of engineering or quality-engineering experience within a manufacturing environment.
- Strong experience with manufacturing quality systems, regulatory requirements, and industry standards.
- Advanced knowledge of blueprint reading and GD&T.
- Hands-on experience with inspection equipment, metrology, and dimensional inspection methodologies.
- Experience with PFMEA, CAPA, nonconformance investigations, root-cause analysis, control plans, and inspection plans
. - Strong statistical quality background, including DOE and capability studies
. - Working experience with Minitab or equivalent statistical analysis tools.
- Experience supporting process and/or equipment validation.
- Experience using ERP and quality-management systems.
- Strong analytical, organizational, communication, and problem-solving skills.
- Ability to work effectively in a fast-paced manufacturing environment.
- Experience supporting injection molding or plastics manufacturing processes
. - Experience with in the medical-device industry
. - Experience working within ISO 13485, FDA-regulated, or similarly controlled manufacturing environments
. - Experience with IQ/OQ/PQ or other formal process-validation methodologies.
This is a fully onsite position in Brooklyn Park, Minnesota
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Candidates must be able to work onsite without relocation assistance.
Applicants must already be legally authorized to work in the United States for any employer.
Visa sponsorship is NOT available now or in the future.
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