Senior Quality Engineer - Penang

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

- Assist different SBUs to manage various local supplier based on One Zimmer Biomet strategy.
- Monitor supplier performance based on established procedures and trigger SCAR and relative action as appropriate.
- 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 appropriate.
- Trouble shooting to any issue related to supplier quality.
- Initiate and follow up the SCAR to close on time.
- Develop supplier from compliance and quality perspective to meet Zimmer Biomet requirements and expectation.
- 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 process and product qualification activities.
- Follow and support manager’s initiatives and participate in supplier quality management improvement projects.
- Lead or support supplier process validation activities and organize SME to review and approve supplier process validation when applicable.
- Lead or support APAC region-based supplier management plan.
- Provide quality leadership for both outside processing manufacturing/services and finished devices to suppliers.

## What Makes You Stand Out

- Professional and ethical conduct.
- Committed to continuously learn as needed to perform the required responsibilities.
- Committed to strive for excellence in the execution of required responsibilities.
- Hi tempo, high pressure in a multi-cultural environment with real challenges
- Have authority to stop supplier production if found significant deviation
- Have authority to reject supplier concession
- Have authority to issue supplier corrective and preventive actions to non-conformities of quality management system

## Your Background

- Bachelor of Science degree or higher, major in Engineering, Mechanical and Material is preferred.
- At least 5 years’ experience with Quality Engineering or Supplier Quality Management or equivalent in medical device company.
- Comprehensive knowledge of ISO13485, US FDA QSR 820.
- Certified ISO13485 Internal Auditor, Certified lead auditor of ISO13485 is plus
- Familiar with machining and surface finishing, final cleaning and packaging process is plus
- Be professional on quality improvement tools SPC, FMEA, MSA, Statistics technique, PPAP etc.
- Good ability to use SCAR/CAPA knowledge to dispose the quality issues.
- Independently capable of managing tasks for multiple project plans simultaneously.
- Strong communication skills in both Mandarin and English.

## Travel Expectations

Yes onsite supplier management in Penang and nearby

EOE/M/F/Vet/Disability