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.