Assistant Quality Manager / Quality Section Manager (Healthcare)

About the role

Jabil is hiring an Assistant Quality Manager / Quality Section Manager for its healthcare medical device business. The role supports the Quality Manager in running Quality Engineering and Quality Assurance so that products meet regulatory requirements, QMS standards, customer needs and company objectives. It provides strategic and technical leadership for manufacturing, NPI, supplier and customer quality, and continuous improvement.

Key responsibilities

• Coach, mentor and develop Quality Engineers, Technicians and Inspectors, set departmental goals and KPIs, and lead quality during customer escalations, crises and product containment.
• Maintain the QMS in line with ISO 13485, FDA 21 CFR Part 820, QSR, RMDSAP and customer requirements, and review and approve quality procedures and records.
• Support manufacturing and NPI with Quality Plans, Control Plans, APQP, process validation (IQ/OQ/PQ), FMEA, risk assessment and SPC.
• Lead investigations of nonconformances, complaints, audit findings and supplier quality issues using 8D, 5 Why and Fishbone methods, and close CAPAs.
• Act as quality interface for customers, leading responses to complaints and audits and supporting qualification, transfers and new product launches.
• Support supplier qualification, SCARs, supplier audits and supplier quality metrics.
• Ensure compliance with equipment, process, software, packaging and test method validation, and lead risk management under ISO 14971.
• Lead internal, customer, supplier and certification audits and inspections, and drive Lean Manufacturing, Six Sigma and operational excellence.

Required profile

• Bachelor's degree in Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Management or a related field.
• Minimum 3-5 years of leadership or supervisory experience.
• Preferred: 7-10 years of quality engineering or assurance experience in medical devices, healthcare or regulated manufacturing, and exposure to SMT, PCBA and HLA assembly.
• Preferred: Lead/Auditor certification (ISO 13485), ASQ CQE or CQA.

Required skills

• ISO 13485, FDA QSR, RMDSAP, ISO 14971
• APQP, PFMEA, Control Plan, CAPA, root cause analysis
• SPC and statistical analysis, process validation
• Supplier and customer quality management, Lean Manufacturing, Six Sigma