Job description
Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!
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
Skills and Abilities (Can Do Criteria):
- 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 Microbiological Test, 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.
- 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.
Your Background
- Bachelor of Science degree or higher, major in Engineering, Mechanical, Microbiology, Mechanical and Microbiology is preferred.
- At least 5 years’ experience with Quality Engineering, Quality Systems or Supplier Quality Management, 3 years work experience in medical device industry.
Physical Requirements
Travel Expectations
Needed as required to meet supplier in Penang and city nearby
EOE/M/F/Vet/Disability