Quality Engineer III - Medical Devices

About the role

Jabil is looking for a Quality Engineer III who leads workcell quality operations or NPI teams, including technicians and inspectors, and ensures product and process compliance with customer, company and regulatory requirements. The role drives quality planning, data analysis, investigations and corrective actions, working with Manufacturing, Engineering, customers and suppliers on continuous improvement.

Key responsibilities

• Lead quality planning, inspection, testing and product release activities, and develop and maintain quality control plans, inspection methods and statistical controls.
• Lead the development, approval and execution of validation activities (IQ, OQ, PQ, TMV, MVP, etc.), including Quality System software validation.
• Ensure compliance with ISO 13485, ISO 9001, 21 CFR Part 820 and applicable procedures.
• Review and approve batch records, manufacturing processes and quality documentation.
• Lead and support CAPA, problem solving, audits and continuous improvement.
• Support new product introduction, transfers, quoting and process development from a quality perspective.
• Monitor quality performance through statistical analysis, SPC, operational metrics and quality system audits.
• Lead, supervise, develop and evaluate Quality Inspectors and Technicians, set team objectives, maintain training matrices and support employee development.
• Support customer, supplier and regulatory audits, including FDA-related activities where applicable.
• Promote a quality, safety and continuous improvement culture, supporting EHS and zero-accident initiatives.

Required profile

• BS degree or equivalent with at least 5 years of experience in a similar Quality role, or a Master's/MBA with at least 4 years of relevant experience.
• Experience in medical device manufacturing, specifically catheter manufacturing, is required.
• Intermediate to advanced written and verbal English.

Required skills

• Working knowledge of regulated Quality Management Systems, including ISO 13485 and ISO 9001.
• ASQ Certified Quality Engineer (CQE) preferred.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).