At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
Job Summary
Onsite management as SQ representative through supplier development, product qualification, inspection, process audit and other control measures.
Principle Duties and Responsibilities⚫ Responsible for BCC existing Supplier Quality Management.
⚫ Monitor supplier performance based on established procedures and trigger SCAR and relative action when there is a deviation.
⚫ Assist different SBUs to manage various local suppliers based on One Zimmer Biomet strategy.
⚫ Be responsible for regular audits/visits/reviews with quality focus at key suppliers.
⚫ Take lead on new supplier qualification to support BCC sourcing project.
⚫ Evaluate supplier by visit or audit
⚫ Follow up supplier corrective action to close out audit findings, as applicable, develop supplier from compliance and quality perspective to meet Zimmer Biomet requirement and timeline.
⚫ Follow and support manager’s initiatives and participate in supplier quality management improvement projects.
⚫ Involve in BCC supplier transfer plan develop and review from quality perspective, lead or participate in product qualification activities.
⚫ Review and support supplier process validation.
⚫ Coordinate supplier change notification with sending site and get it approved.
⚫ Trouble shooting to any issue related to quality.
✓ Skills and Abilities (Can Do Criteria):
✓ Bachelor of Science degree or higher, major in Engineering, Mechanical, Electrical, Mechanical and Electrical Engineering is preferred.
✓ At least 5 years’ experience with Quality Engineering, Quality Systems or Supplier Quality Management, 3 years work experience in active medical device industry.
✓ Comprehensive knowledge of ISO13485, US FDA QSR 820.
✓ Certified ISO13485 Internal Auditor, Certified lead auditor of ISO13485 is plus
✓ Familiar with SMT, PCBA, re-flow welding, wave-soldering, etc., familiar with UL, IEC60601-1/GB9706.1 is plus
✓ Familiar with machining, injection molding process is plus
✓ Basic Knowledge on MSA, SPC, Statistics technique, PPAP etc.
✓ Understanding of quality tools.
✓ Excellent PC skills. Strong Word, Excel and PowerPoint skills.
✓ LANGUAGE SKILLS in both Mandarin and English.
✓ Strong communication skills.
✓ Personal Traits (Will Do Criteria):
✓ Professional and ethical conduct.
✓ Committed to continuously learn as needed to perform the required responsibilities.
✓ Hi tempo, high pressure in a multi-cultural environment with real challenges.
Needed as required
Travel ExpectationsEOE/M/F/Vet/Disability