Quality Engineer

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.

• 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.
• Hands-on experience managing CAPA, nonconformance, deviation, root-cause analysis, and corrective action processes.