- 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 Compliance
Lead 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 Improvement
Apply risk management principles (ISO 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 & Reporting
Define 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
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