Medical Device - Quality Manager - 6 Sigma expert

上海全职 RMB500,000 - RMB800,000 年薪 View Job Description

职责描述
职位概要
类似职位

A global well-known MNC, providing a great platform for career development.
Highly involved in company strategy.

关于我们的客户

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.

职责描述

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).

理想的求职者

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.