Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Position summary:

This Role will report to Sr. Quality Manager. The position is Leading the quality management for division GSD/CSD, BID and BPG. Which should guarantee compliance of quality management and continuous to meet customer & business quality needs.

Key Responsibilities:

• Lead the quality assurance of responsible division, including:
  • Work closely with main local and global stakeholders to ensure timely product disposition, quality issue handling, return, rework and release.
  • Define and follow 3PL and In-direct supplier quality supervision policy according to business and regulation trend.
  • Ensure post-market surveillance management, includes customer complaints, recall, PRER, AE handling etc.
  • Support quality policy /standard evaluation for relevant business projects.
• Ensure timely and proper quality response to customer requests, including:
  • Host customer audits and ensure results and response.
  • Review quality agreements and questionnaire, and provide timely respond
• Leading the issue solving as quality representative and providing quality guide to the organization
• Support quality system maintenance of related business, including:
  • Support external and internal audits related to the above business
  • Lead process review and modification according to assignment
• Lead the team for achieving goals and satisfying business needs, including:
  • Team performance management for achieving goals.
  • Team cultivation for talent retention and team development

REQUIREMENTS:

• Bachelor’s degree above on subjects of medical device/life science/chemistry or other relevant science
• over 5 years professional work experience of quality management in MD industry
• 3-5 years of leadership/management experience
• good regulation and quality knowledge of GSP, ISO 13485, ISO 9001
• good English skill (both oral and written are required)
• experienced People management skills
• Strong inter-personal skills for cross team collaboration, communication, and stakeholder mgt