My client is a global name in the medical devices industry and is going through a period of rapid expansion.
Volt has supported this medical device firm in filling several new positions in 2020 - Service Engineer, Intellectual Property Engineer, Embedded Software Engineer, R&D Systems Engineer and a Project Manager. The final role is a Senior/Manufacturing Quality Engineer
- Apply quality engineering principles and methods to ensure compliance with regulatory requirements in areas of product development, manufacturing and distribution
- Investigate complex manufacturing product quality and compliance issues (e.g. non-conformances, CAPA, audit observations) for all production processes leading to product release.
- Lead project team in risk analysis, manufacturing quality control, supplier management, and process validation activities.
- Review and approve test protocols with application of statistical analysis in design of experiments, feasibility and characterization studies, IQ/OQ/PQ/PPQ process validation, validation of equipment, test protocols/ methods, software validations, and manufacturing processes.
- Establish and maintain content of risk management documents, product specification, inspection methods and sampling plans
- Liaise and co-ordinate with cross functional team for verification and validation activities; production and process controls; Corrective & Preventive Action (CAPA), complaints & risk management; product quality improvement and root cause analysis.
- Improve product manufacturing process in terms of design of manufacturing and for continuous improvement
- Degree/master's in engineering/Manufacturing or Biotechnology with at least 5-7 years' experience in manufacturing or quality assurance within medical devices
- Stronghold with medical device regulations like, quality management system (ISO 13485) and 21 CFR Part 820.
- Familiarity with other medical device-related ISO standards (ISO 14971, ISO 10993, IEC 60601) and non-sterile/sterile product lot release.
- Proficient in quality management system processes such as document control, design control, supplier management, CAPA, internal audits, IQ, OQ, PQ, production and process-related software validations.
- Certified Quality Engineer qualifications preferred
- Six Sigma Green Belt certification will be highly desired
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).