Mgr Supplier Quality (Medical Devices)

Location: Shanghai, China; full-time onsite role

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions across Innovative Medicine and MedTech.

What you will do

• Lead supplier quality management, purchasing controls, manufacturing quality, product release, and quality system activities within the assigned scope.
• Develop risk-based supplier quality strategies covering supplier selection, qualification, monitoring, performance management, and corrective actions.
• Review manufacturing and sterilization records, approve quality documentation, and authorize product release as assigned.
• Lead or support CAPA, nonconformance management, validation, calibration, supplier corrective actions, and audit readiness.
• Analyze supplier and quality performance data, identify trends and risks, and provide recommendations to management.
• Collaborate with Procurement, Manufacturing, Engineering, R&D, Regulatory Affairs, Supply Chain, Commercial, and Quality Compliance teams.

Requirements

• Bachelor’s degree in Engineering, Science, Life Science, or a related technical field.
• Experience in supplier quality, purchasing controls, manufacturing quality, quality systems, or regulatory compliance.
• Minimum 7 years of medical device industry experience is preferred.
• Working knowledge of medical device quality and regulatory requirements, including 21 CFR Part 820, ISO 13485, China GMP, ISO 14971, EU medical device requirements, and MDSAP jurisdictions.
• Experience with medical device manufacturing and sterilization processes, including extrusion, plastic injection molding, assembly, cleanroom packaging, and validation of supporting infrastructure.
• Fluent English and strong written and verbal communication skills; proficiency with Microsoft Word, Excel, and PowerPoint.

Nice to have

• People management, coaching, mentoring, or technical leadership experience.
• Knowledge of microbiology, statistical methods, Lean, and Six Sigma.
• ASQ, Six Sigma, Lean, PMP, or equivalent certification.

Culture & Benefits

• Inclusive work environment based on individual dignity, diversity, and merit.
• Cross-functional collaboration across healthcare, manufacturing, engineering, regulatory, and commercial functions.
• Responsibility for compliance with health, safety, environmental, regulatory, and quality requirements.