Quality engineer

Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ 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 Resp

Hi, Our client is looking for Quality Manager in Reedsville, PA below is the detailed requirement. Job Title: Quality Manager Location: Reedsville, PA Job Description: Bachelor's or Master's degree in Engineering or related discipline. 12+ years of Medical Device Quality experience. 5+ years of Quality Management leadership experience. ISO 13485 Lead Auditor or ASQ/CQI certification preferred. Experience supporting FDA inspections and remediation programs Medical Device Quality Manageme

Job Summary: Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams. Key Responsibilities: Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.Support FDA inspections and regulatory audits.Drive quality remediation and compliance initiatives.M

Job Summary Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams. Key Responsibilities Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs. Support FDA inspections and regulatory audits. Drive quality remediation and compliance initiatives.