Quality Engineer - Medical Devices

About the role

Jabil is looking for a detail-oriented Quality Engineer with experience in the medical device or healthcare products industry. The role ensures compliance with regulatory standards and drives continuous improvement in product quality and manufacturing processes. The work involves office and manufacturing floor interaction, and may include audits, inspections and supplier visits.

Key responsibilities

• Maintain the Quality Management System (QMS) in line with ISO 13485 and regulatory requirements
• Lead and support CAPA investigations, root cause analysis and effectiveness checks
• Perform internal and supplier audits and support external regulatory audits (FDA, notified bodies)
• Review and approve design documentation (DHF, DMR, DHR)
• Take part in risk management (ISO 14971), including hazard analysis, FMEA and risk controls
• Collaborate with R&D, Manufacturing and Regulatory Affairs on new product development and process validation
• Ensure GMP compliance and handle non-conformance reports and deviation investigations
• Support validation activities (IQ/OQ/PQ, software validation, process validation)
• Manage supplier quality, including qualification, monitoring and evaluation
• Analyse quality data and run continuous improvement initiatives (Lean, Six Sigma)

Required profile

• Bachelor's degree in Engineering, Biomedical, Life Sciences or a related field
• 3-8 years of quality engineering experience in the medical device, pharmaceutical or healthcare industry
• Preferred: CQE certification, Six Sigma Green/Black Belt, experience with sterile products, Class II/III devices, regulatory submissions (510(k), CE marking), electronic QMS, supplier quality, and HLA SMT (PCBA) manufacturing

Required skills

• ISO 13485, FDA 21 CFR Part 820 and ISO 14971
• CAPA, audits, validation and document control
• Statistical tools and quality methods (SPC, Six Sigma, root cause analysis)
• Problem-solving, analytical and communication skills