My client is one of the most innovative med-tech companies in Singapore. It now seeks an experienced Product Quality Engineer to manage the design, development, and technical problem solving of my client's products in accordance with Quality Systems and customer requirements.
- Assume responsibility for ensuring the completeness and quality of the associated design controls and documentation for products especially in the areas of design requirements, risk management and testing documentation.
- Lead project team in risk analysis, material qualifications, supplier management, and validation activities.
- Review design of experiments, feasibility studies, test protocols, software, and manufacturing processes
- Establish risk management documents, design requirement documents, product specification, inspection method and sampling plan.
- Lead in thorough investigations of product quality issues and effective corrective and preventative action
- Work closely with a multidisciplinary team to coordinate pilot production of new products and accomplish tasks
- Degree/Master's in engineering or Science with at least 5 - 7 years' of direct quality engineering/QA/Product Quality experience from medical/biotech industry
- Proven ability of analytical problem solving and troubleshooting.
- Experience with Design Control procedures and requirements engineering.
- Stronghold with Risk management, risk analysis, FMEA.
- Familiarity with 21 CFR Part 820, ISO 13485, and other medical device standards (ISO 14971, IEC 60601).
- Proficient in quality management system processes such as, document control, design control, supplier management, CAPA, internal audits, and IQ, OQ, PQ,
- Software Validation and Design of Experiments (DoE) experience is a plus
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).