Job Summary: We are seeking an experienced Quality Engineer to lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/III medical devices in a regulated manufacturing environment. The ideal candidate will have strong expertise in manufacturing quality engineering, process validation, risk management, CAPA, supplier quality, and regulatory compliance. Roles & Responsibilities:
Lead manufacturing quality assessments, process audits, and remediation activities for medical device manufacturing processes.
Drive First Pass Yield (FPY) improvement, defect reduction, scrap reduction, and manufacturing process improvement initiatives.
Review and approve process validation (IQ/OQ/PQ) protocols, reports, and supporting documentation.
Evaluate Test Method Validation (TMV) activities to ensure measurement methods are accurate, reliable, and appropriately validated.
Conduct and review SPC, MSA, PFMEA, process capability, and statistical analyses to identify and mitigate manufacturing risks.
Support development and implementation of manufacturing quality improvement strategies and risk-reduction programs.
Manage and provide technical support for CAPA, nonconformance, deviation, and corrective/preventive action activities.
Investigate manufacturing defects and quality issues using structured root-cause analysis and problem-solving methodologies.
Monitor quality metrics, manufacturing trends, process performance, and corrective action effectiveness.
Support supplier quality activities, including supplier assessments, quality issues, corrective actions, and supplier performance monitoring.
Review manufacturing processes and quality systems for compliance with applicable regulatory and quality requirements.
Support FDA, ISO 13485, MDSAP, and other regulatory audits and inspections.
Collaborate with Manufacturing, Engineering, R&D, Supplier Quality, Regulatory Affairs, and Operations teams to resolve quality issues and implement sustainable improvements.
Ensure appropriate quality documentation, records, and objective evidence are maintained in accordance with applicable procedures and regulations.
Identify opportunities for continuous improvement, process optimization, and manufacturing risk reduction.
Education & Experience:
Bachelor's degree in Engineering, Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, Quality Engineering, or a related technical discipline.
Master's degree in Engineering or a related field is preferred
8+ years of experience in Medical Device Manufacturing Quality Engineering or a closely related quality function.
Demonstrated experience with process validation (IQ/OQ/PQ), Test Method Validation (TMV), SPC, MSA, PFMEA, and process capability analysis.