Medical Device - Quality Manager - 6 Sigma expert

Shanghai 全职 RMB500,000 - RMB800,000 per year View Job Description
We are seeking an experienced and certified ​​Quality Manager​​ to lead quality assurance, risk management, and regulatory compliance for our medical device manufacturing operations. The ideal candidate will have a strong background in ​​quality management systems (QMS)​​, ​​risk-based quality management​​, and ​​6 Sigma (Green Belt/Black Belt)​​ methodologies.
  • 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 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 & 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 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

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.

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