Save Job Back to Search Job Description Summary Similar Jobs A global well-known MNC, providing a great platform for career development. Highly involved in company strategy. About Our Client My client is a global medical device manufacturer specializing in innovative, high-quality healthcare solutions. they are dedicated to improving patient outcomes through cutting-edge technologies in e.g., diagnostics, surgical instruments, or implantable devices. Job Description Quality Assurance & Regulatory ComplianceLead the implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, MDR, and other applicable regulations.Review and approve quality-related documentation, including CAPA, risk assessments, and validation protocols.Ensure smooth audits (internal, customer, and regulatory) with zero major findings.Manage supplier quality and conduct audits to ensure compliance with quality standards.Risk Management & Process ImprovementApply risk management principles (ISO 14971) to identify, assess, and mitigate risks in product design, manufacturing, and post-market surveillance.Drive process improvements using 6 Sigma methodologies (Green Belt/Black Belt certification required) to optimize yield, reduce defects, and improve efficiency.Lead Root Cause Analysis (RCA) and Corrective & Preventive Actions (CAPA) to address quality deviations and ensure sustainable solutions.Supervise a team of quality engineers, inspectors, and regulatory affairs staff.Collaborate with R&D, manufacturing, and supply chain to ensure quality is integrated at every stage of the product lifecycle.Mentor and train team members on quality systems, risk management, and continuous improvement tools.Metrics & ReportingDefine and track Key Performance Indicators (KPIs) for quality performance (e.g., defect rates, audit scores, CAPA closure rates). The Successful Applicant Education: Bachelor's degree in Engineering, Quality Management, or related field (Master's or additional certifications are a plus).Certifications: 6 Sigma Green Belt or Black Belt (required); additional certifications (e.g., ASQ CQE, RAC) are advantageous.Minimum 5-7 years of experience in quality management in the medical device industry.Proven track record in process improvement, regulatory compliance, and risk management.Expertise in ISO 13485, FDA QSR, MDR (EU 2017/745), and ISO 14971.Proficiency in Quality tools (FMEA, DOE, SPC, QFD, Pareto Analysis).Familiarity with QMS software (e.g., MasterControl, ETQ, SAP QM).Language: Fluent in English (written & spoken); Mandarin is a plus. What's on Offer Opportunities for professional growth in a global medical device expert.A collaborative, innovation-driven work environment. Contact Ray Gong Quote job ref JN-052025-6740295 Phone number +8621 6062 3109 Job summary Function Engineering & Manufacturing Specialisation Quality, Technical What is your area of specialisation? Industrial / Manufacturing Location Shanghai Contract type Permanent Consultant name Ray Gong Consultant phone +8621 6062 3109 Job Reference JN-052025-6740295
