Senior Quality Engineer

1 week ago

Singapore CAREER CONNECT CONSULTANCY Full time

**Product Design**
- Participate in new/modified product development projects and support deliverables required for each design phase, such as product specification establishment, manufacturing process, sterilization validation activities, test plan/report review and approval.
- Evaluate product related changes initiated by R&D and/or contract manufacturer. Assist with the development of required documentation or justification to support proposed change
- Support and provide inputs to product related issue such as non-conformity, complaint, CAPA and Supplier CAPA.
- Review and maintain post-market surveillance data and files, include tracking of product related NC, CAPA status.
- Maintain risk management file and product design related risk analysis documents (e.g. Hazard Analysis, dFMEA, uFMEA)

**Others**
- Review complaint investigation results for adequacy and closure.
- Review equipment calibration/maintenance, storage environment and pest control data.
- Perform internal audits
- Support supplier audits and external regulatory body audits.
- Analyze and track product quality data/metrics in support of Quality Objective and Management Review
- Support and provide inputs to other non-product related issues such as non-conformity, complaint, and CAPA
- Support quality system implementation projects
- Any other tasks as assigned

**REQUIREMENTS**:

- Bachelor’s degree or diploma in Science, Engineering, Quality or similar discipline
- For degree holder, 5 or more years of experience in quality, R&D and/or manufacturing function in medical device industry
- For diploma holder, 8 or more years of experience in quality, R&D and/or manufacturing function in medical device industry
- Good understanding of ISO 13485, EU Medical Device Directive / EU Medical Device Regulations and FDA QSR Part 820
- Internal auditor trained in ISO 13485, ideally with lead auditor certification
- Preferably with prior experience in manufacturing, product validation, gamma/EO sterilization and/or statistical analysis.

**OTHER QUALIFICATIONS**:

- Independent, high level of initiative and ownership to drive department and organization goals
- Good problem-solving skills
- Proactive and ability to work well with cross-functional departments and stakeholders in a constructive manner
- Excellent interpersonal and communication skills (both verbal and written) that allow for effective communication within all levels of organization

Samonte Rodeliza Sabiano
R2197226
EA license No. 16C0441

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