Quality Engineer
2 weeks ago
**Quality Engineer (SG ENDOSCOPY PTE LTD)**
**JOB DESCRIPTION**
responsible for supporting Business Development & Engineering/R&D via meetings with prospective
Quality Manager and must be able to function with little supervision.
**JOB RESPONSIBILITIES**
Design Risk Management activities)
- 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.
**JOB 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
- The ability to perform statistical analysis using k-factors, PpK, or capability indices as well as sample
- 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
If you are looking for challenges and have the qualities and experience to undertake this challenging
experience, present and expected salary, and notice period.
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