Quality Engineer - Medical Device Industry

Job DescriptionJob Description + About the job: The Quality Engineer will ensure compliance with regulatory standards and support continuous improvement in manufacturing processes and products. This role collaborates with cross-functional teams to maintain quality systems, investigate non-conformances, and drive initiatives that enhance product quality and efficiency. + We’re looking for someone who: Has a bachelor’s degree in Engineering, Quality Assurance, or a related field (advanced degree ) Brings 5+ years of quality engineering experience in the medical device industry Understands ISO 9001, ISO 13485, and CFR 820 standards and requirements Excels at root cause analysis, CAPA management, and NCR resolution Is detail-oriented, analytical, and committed to compliance and quality excellence Communicates effectively and works collaboratively with cross-functional teams () Has experience with cleanroom operations and contamination control practices () Has experience in supplier quality management, including audits and SCARs () Holds CQE or CQA certification + What you’ll do: Investigate and resolve non-conformances, deviations, and customer complaints using CAPA methodologies Generate and manage CAPAs, NCRs, and corrective actions to ensure timely resolution Update and revise SOPs, quality procedures, and work instructions for compliance and efficiency Perform inspections of finished goods, raw materials, and components to verify compliance with specifications Oversee equipment calibration and ensure accuracy of test and measurement systems Provide quality-related guidance and support to manufacturing teams Conduct supplier audits and assessments to evaluate performance and compliance Participate in cleanroom activities and ensure compliance with ISO 14644 standards Analyze data, identify trends, and implement best practices to drive continuous improvement

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