Senior / Quality Engineer

1 day ago

Woodlands, Singapore Venture Corporation Limited Full time

**About The Role**

The key responsibilities are as below:

- Maintain effectiveness of production quality inspection, by revising QCVMI/ OQA checklists template in the electronic Document History Record setup; guiding the inspectors; and highlighting the inspection findings to Production and Engineering stakeholders for improvement; and conducting periodic GMP line audits
- Material issues handling; coordinating Purge as necessary; Escalating the issue based on the tier requirement; summarizing monthly the Non-Conforming Material reports, and Monitoring reports on key suppliers; coordinating Return to Supplier and investigation, containment and corrective actions; conducting annual Assessment on Supplier Risk and Audit/Re-Evaluation requirements; and providing Quarterly Key Supplier performance review data to corporate
- Attend weekly meetings with customers, reporting on First Pass Yield, Material Issues, and Customer Returns investigation. And monthly technical review summarizing the issues, status, and dashboard
- Ensuring QA roles related to Engineering Change Order (ECO), and Temporary Manufacturing Deviation (TMD) are performed timely, and monitoring the status until closure
- Acknowledge customer complaints or corrective action requests (CAR); issue Quality Alert and brief internal stakeholders; coordinate Containment Actions, Root Cause investigation and CAPA process until effective closure with the customers
- Prepare and manage audits from customer and product safety certification bodies, including timely investigation and closure to all findings.
- Drive improvement projects on Quality, Digitalization, Productivity and Sustainability for the customer
- Prepare Quality inspection checklists for IQA and IPQA/OQA for new product introduction; review adequacy of NPI documentation on Control Plan, DHR, PFMEA and manufacturing instructions; perform First Article Qualification tasks; and conduct Dock-To-Stock assessment for customer approval

**About You**
- Degree in Engineering and/or any related field
- Minimum 3 years of experience in the Medical Device manufacturing industry, and supervisory experience in the Quality team
- Knowledge of ISO9001, ISO13485, ISO14001, and FDA 21 CFR Part 820 & Part 11, cGMP
- Good communication and leadership that able to drive/motivate team
- Knowledge in Microsoft Office
- Hands-on experience in SAP Material Master and Quality modules will be advantageous

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