Senior R&D Quality Engineer
Date Submitted: 05-03-2020 | End date:
| Industry Specialization | : | Power electronics |
| Type of Employment | : | |
| Minimum Experience | : | 5 years or more |
| Work Location | : | Southwest Singapore |
These may include, but are not limited to:
- Champion the development and maintenance of ISO9000 and ISO13485 Quality Management System (QMS) for the R&D department
- Develop Product Quality Plan, documents and systems in conjunction with product development teams
- Interface with regulatory agencies and actively manage Design Controls and Design History files.
- Review and approve design verification and validation documentation
- Drive risk assessments and FMEAs for medical and non-medical products
- Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements
- Work with R&D engineers to develop the test qualification plans and execute them
Job Requirements:
- Bachelor/Master degree in Electrical/Electronics, Mechanical, Quality Engineering or equivalent. ASQ certification preferred
- Minimum 5 years of working experience in Quality, R&D or similar product development environment in the medical industry
- Good knowledge of medical risk management practices and ISO14971
- Experience in implementation of Quality Management System, medical product development (Class I/II/III) and design controls based on ISO9000, ISO13485, 21 CFR Part 820.
- Good interpersonal skills, work well with other team members in a collaborative environment