Note: The job is a remote job and is open to candidates in USA. Talent Groups is seeking a Quality Engineer – Medical Devices to support manufacturing quality and regulatory compliance. The role leads quality assessments, audits, process validation reviews, CAPA and nonconformance management, supplier quality activities, and continuous improvement initiatives for medical device manufacturing.
Responsibilities
- Lead manufacturing quality assessments, audits, and continuous improvement initiatives
- Drive FPY improvement, defect reduction, and manufacturing risk reduction
- Review IQ/OQ/PQ process validations, TMV, SPC, MSA, and PFMEA
- Manage CAPA, nonconformances, and supplier quality issues
- Support FDA, ISO 13485, MDSAP, and regulatory audits/inspections
- Review manufacturing processes and quality metrics to identify improvement opportunities
Skills
- Manufacturing Quality Engineering experience
- Strong Process Validation / TMV experience
- Expertise in SPC, MSA, and PFMEA
- CAPA and Nonconformance Management
- Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971
- 8+ years of medical device manufacturing quality experience
- Class II/III medical device experience preferred
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