Zimmer Biomet Hiring! Work from Home Supplier Quality Engineer - Penang in - Ricebowl

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