Quality engineer
Full-time
Programmers.io
mary:
Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/III medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments.
Key Responsibilities:
- Lead manufacturing quality assessments and process audits.
- Drive FPY improvement and defect reduction initiatives.
- Review process validation (IQ/OQ/PQ) and risk management activities.
- Manage CAPA, nonconformance, and supplier quality issues.
- Support FDA, ISO 13485, MDSAP, and regulatory audits
Required Skills:
- Manufacturing Quality Engineering.
- Process Validation and TMV.
- SPC, MSA, and PFMEA.
- CAPA and Nonconformance Management.
- FDA 21 CFR Part 820, ISO 13485, ISO 14971
Preferred Qualifications:
- Bachelor's/Master's degree in Engineering discipline.
- 8+ years of Medical Device Manufacturing Quality experience.
- Experience with Class II/III medical devices.
- Experience supporting regulatory audits and inspections
Vacancy posted 20 hours ago
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