Quality Engineer Medical Device Manufacturing
Listed on 2026-06-27
-
Quality Assurance - QA/QC
Quality Engineering, Production QC/QA, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers -
Engineering
Quality Engineering, Regulatory Compliance Specialist
Quality Engineer – Medical Device Manufacturing
Position Summary:
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
- 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
- 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
- Analyze quality trends and support data‑driven improvements
- Improve inspection methods, sampling plans, and process controls
- Support cross‑functional problem solving and operational improvements
- 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.
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.
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).