Quality Manager – Medical Devices (Suzhou)
Your Job
You will provide strategic direction and leadership to the Quality Organization for Phillips-Medisize Suzhou, ensuring product quality, regulatory compliance, and continuous improvement across the full product lifecycle.
What You Will Do
- Lead product and facility regulatory activities, including submissions, reporting, and regulatory agency communications
- Serve as a key interface with customers and regulatory bodies to support business development
- Define and deploy quality system and compliance strategies to mitigate product and regulatory risks
- Establish and monitor site Quality KPIs and compliance metrics
- Conduct management reviews and ensure effective data analysis and reporting
- Lead and maintain the Quality Management System (QMS), ensuring alignment with regulatory and customer requirements
- Develop and deliver internal quality training programs to enhance team capabilities
- Provide leadership to the Quality team, including hiring, development, performance management, and communication
- Plan and forecast resource needs based on business priorities
- Drive global and regional quality initiatives within the manufacturing site
- Lead quality assurance, risk management, and compliance across the entire product lifecycle
- Oversee investigations related to customer complaints and adverse events
- Collaborate cross-functionally to drive cost reduction and continuous improvement
- Support production release activities for key products
- Ensure compliance with EHS regulations and promote a safe working environment
Who You Are
- Bachelor’s degree in medical device-related or technical field (or equivalent professional qualification)
- Significant experience in Quality/Compliance environments, including leadership experience in quality organizations
- Expertise in medical device regulatory submission lifecycle activities
- Experience with regulatory requirements such as FDA CFR, ISO13485, and NMPA (EU MDR is a plus)
- Strong experience in cGMP / GXP environments
- Strategic thinker with strong problem-solving and technical capabilities
- Excellent communication and stakeholder management skills
- Proven ability to work effectively in a global matrix organization
- Project management capability
Our Team
You will work closely with global and regional quality leaders, plant operations teams, project teams, and business development teams, as well as external partners including customers, suppliers, and regulatory agencies.
Location
Suzhou, China