Summary:
Seeking an experienced Manufacturing Quality Engineer to lead quality assessments, remediation, validation, and continuous improvement within a regulated medical device manufacturing environment.
Roles & Responsibilities:
- Lead manufacturing quality assessments and process audits.
- Drive First Pass Yield (FPY) improvement and defect reduction.
- Review process validation activities, including IQ/OQ/PQ.
- Support risk management and PFMEA activities.
- Manage CAPA, nonconformances, and supplier quality issues.
- Apply SPC, MSA, TMV, and manufacturing quality tools.
- Support FDA, ISO 13485, and MDSAP audits and inspections.
- Drive manufacturing risk reduction and quality improvement initiatives.
Required Qualifications:
- 8 years of Medical Device Manufacturing Quality experience preferred.
- Class II/III medical device experience.
- Strong process validation and TMV expertise.
- Experience with CAPA and nonconformance management.
- Knowledge of FDA 21 CFR Part 820/QMSR.
- ISO 13485 and ISO 14971 expertise.
- SPC, MSA, PFMEA, and supplier quality experience.
- Engineering bachelor's or master's degree preferred.
