Job Summary We are seeking an experienced Senior Quality Engineer to support medical-device quality systems, product development, design controls, risk management, process validation, and regulatory compliance. The ideal candidate will have strong hands-on experience in CAPA, root cause analysis, non-conformance investigations, design verification and validation, and compliance with applicable FDA regulations and ISO standards.
Roles& Responsibilities- Support new product development and maintain quality deliverables in accordance with medical-device design control requirements.
- Develop, review, and approve design verification and validation protocols, reports, and support documentation.
- Develop and maintain product risk management documentation, including DFMEA, PFMEA, and risk assessments.
- Lead and support CAPA, non-conformance, deviation, root cause analysis, and engineering change-control activities.
- Execute and review process validation, equipment qualification, and IQ/OQ/PQ activities.
- Support internal and external audits, regulatory inspections, and quality system compliance initiatives.
- Analyze quality metrics, investigate trends, and support post-market surveillance and customer complaint investigations.
- Review engineering drawings, product specifications, tolerances, GD&T requirements, and manufacturing documentation.
- Develop and maintain Quality Plans, SOPs, work instructions, and validation documentation.
- Collaborate with R&D, Manufacturing, Regulatory Affairs, Supplier Quality, and cross-functional engineering teams.
- Support technical transfers, manufacturing transfers, and process implementation while ensuring compliance with applicable quality standards.
- Drive continuous improvement initiatives to enhance product quality, process capability, and overall quality system effectiveness.
Education & Experience- Bachelor's degree in engineering, Biomedical Engineering, Life Sciences, or a related technical field.
- Minimum of 5 years of quality engineering experience in the medical-device industry or another regulated life-sciences environment.
- Strong knowledge of FDA Quality System requirements, Good Manufacturing Practices (GMP), and ISO 13485.
- Experience with ISO 14971, design controls, and medical-device risk management.
- Hands-on experience with CAPA, root cause analysis (RCA), non-conformances, deviations, and change control.