Quality Engineer Medical Device Manufacturing
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Overview
Job Description
We are seeking a Quality Engineer to support manufacturing quality operations in a regulated medical device environment. This role is responsible for ensuring product quality, supporting production activities, and maintaining compliance with ISO 13485 and FDA requirements.
The Quality Engineer will play a key role in driving product quality, supporting manufacturing and process transfers, and strengthening the Quality Management System (QMS) through hands-on floor support and structured problem solving.
Key Responsibilities
Production Quality Support
- Support in-process inspection, final release, and lot history record review
- Lead MRB activities and disposition of nonconforming material
- Support supplier and customer quality issue resolution
- Monitor supplier quality performance and corrective actions
- Review complaints and returned product investigations
Quality Systems & Compliance
- Support ISO 13485 and FDA 21 CFR Part 820 compliance
- Participate in internal and external audits and audit readiness activities
- Lead or support CAPA investigations and root cause analysis
- Support risk management activities (PFMEA, control plans)
- Support change control and documentation updates
Process & Facility Transfer Support
- Support quality oversight of process and facility transfers
- Partner with engineering and operations on validations and requalification activities (IQ/OQ/PQ)
- Update inspection methods, control plans, and quality documentation during transfers
- Ensure process controls, SPC, and quality metrics are implemented and maintained
Continuous Improvement
- Analyze quality trends and support data-driven improvements
- Improve inspection methods, sampling plans, and process controls
- Support cross-functional problem solving and operational improvements
Qualifications
- 5+ years of quality engineering experience in medical device or regulated manufacturing
- Strong knowledge of ISO 13485 and FDA 21 CFR Part 820
- Experience with CAPA, root cause analysis, and audit support
- Experience supporting manufacturing operations and production floor quality issues
- Familiarity with SPC, MSA, and statistical tools (Minitab preferred)
- Experience supporting product or process transfers strongly preferred
- ASQ certification (CQE/CQA) preferred
Must be eligible to work in the United States without restriction and without the need for current or future sponsorship.
Resumes can be confidentially sent to eli.stader@gogpac.com or call direct at (319)774-8916.
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations. GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.
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