Global Supplier Quality Engineer (Medical Devices)

Zimmer Biomet; Malaysia; Remote; MYR 120,000 - 180,000; Full time

Job summary

Zimmer Biomet seeks a Supplier Quality Engineer to oversee supplier development, qualification, audits, and process validations across local suppliers in Malaysia. The role supports One Zimmer Biomet strategies and requires strong ISO13485 knowledge, plus hands-on experience with medical devices.

You will work closely with cross-functional teams, drive corrective actions, and lead supplier-related improvement projects in a high-paced environment.

Qualifications

• Bachelor of Science degree or higher, major in Engineering, Mechanical or Microbiology.
• At least 5 years of experience with Quality Engineering, Quality Systems or Supplier Quality Management.
• 3 years work experience in medical device industry.
• ISO13485 knowledge and FDA QSR 820 familiarity.
• Auditing: ISO13485 Internal Auditor and lead auditor is a plus.
• Familiar with machining, injection molding, and secondary processing processes.
• Familiar with microbiological testing and sterile packaging processes.
• Knowledge of quality tools and problem solving.

Responsibilities

• Onsite management as SQ representative through supplier development, product qualification, inspection and audits.
• Collaborate with MNO team to ensure timely transfer of projects and NPI.
• Lead or support supplier process validation activities.
• Manage and coordinate Supplier Change Notifications.
• Lead or participate in supplier qualification activities.
• Regular audits/visits/reviews with quality focus at key suppliers.
• Follow up supplier corrective actions to close out audit findings.
• Assist SBUs to manage local suppliers per One Zimmer Biomet strategy.
• Troubleshoot supplier quality issues and drive improvements.

Skills

Mandarin

English

Communication skills

PC skills

Education

Bachelor of Science degree or higher (Engineering / Mechanical / Microbiology)

Tools

MSA

SPC

PPAP

Job description

Zimmer Biomet seeks a Supplier Quality Engineer to oversee supplier development, qualification, audits, and process validations across local suppliers in Malaysia. The role supports One Zimmer Biomet strategies and requires strong ISO13485 knowledge, plus hands-on experience with medical devices.

You will work closely with cross-functional teams, drive corrective actions, and lead supplier-related improvement projects in a high-paced environment.