Supplier Quality Engineer - Penang

Zimmer Biomet; Malaysia; Remoto; MYR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Mandarin

English

Communication skills

PC skills

Formazione

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

Strumenti

MSA

SPC

PPAP

Descrizione del lavoro

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.

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.

Travel Expectations

Needed as required to meet supplier in Penang and city nearby

EOE/M/F/Vet/Disability