What You Can Expect

Onsite management as SQ representative through supplier development, product qualification, inspection, process audit and other control measures.

Collaborate with MNO(Manufacture Network Optimization) team ensure the timely and efficiency of work to transfer project and NPI (New Product Introduction) as appropriate

How You'll Create Impact

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/existing supplier qualification and on-site audit to support business demand.

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.

Manage and coordinate Supplier Change Notification to be processed in a timely manner.

Involve in BCC supplier transfer plan develop and review from quality perspective, lead or participate in product qualification activities.

Lead or support supplier process validation activities

Troubleshooting to any issue related to supplier quality.

Follow and support manager’s initiatives and participate in supplier quality management improvement projects.

What Makes You Stand Out

Your Background

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 medical device industry.

Comprehensive knowledge of ISO13485, US FDA QSR 820.

Certified ISO13485 Internal Auditor, Certified lead auditor of ISO13485 is plus

Familiar with machining, injection molding, secondary processing processes (Anodizing, Passivation/Electrical Polishing, Heat Treatment, welding etc.) is plus

Familiar with End of Line process (Cleanroom, Final cleaning, Upgrade) and sterile barrier packaging 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.

Travel Expectations

Needed as required