Quality engineer

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 #J-18808-Ljbffr Programmers.io