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Quality Engineer

3 weeks ago

Singapore SG ENDOSCOPY PTE. LTD. Full time

**Job Description**:
Roles and Responsibilities Include:

- Working with NPD team to research and qualify new suppliers according to Risk Management Plan
- Leading cross functional teams in creation of dFMEA, pFMEA, and RMP compliant with ISO-14971.
- Maintain and improve the Quality Management System.
- CAPA ownership and/or support.
- Interacting effectively with customers, suppliers, and internal resources.
- Managing projects and/or providing project support from the Quality function.
- Facilitating the identification of project risks, develops, drive and manage mitigation action plan
- Performing root cause analysis and corrective actions.
- Effectively employing problem solving tools/methodology
- Other responsibilities as assigned.

**Requirements**:

- A Bachelor’s degree in related engineering or technical field (e.g. Mechanical, Bioengineering)
- A minimum of 3+ years related work experience in the medical device field
- A working understanding of ISO-13485, ISO-14971, GLP, 21 CFR 820 and other relevant QMS
- Experience working through all aspects of medical device design/development including

Design verification & validation, Process validation, Design Transfer, Post market Surveillance, Complaint Handling etc is preferred.
- An understanding of design for manufacturability and assembly / design for six sigma (DFMA/DFSS)
- Experience with test method development & validation (e.g. measurement/test protocol development, GR&R, DoE etc.)
- Experience and understanding of manufacturing processes for metals and polymer is an advantage