Senior Manufacturing Quality Engineer, Medical Devices

  • Location

    Singapore

  • Sector:

    Engineering & Manufacturing

  • Job type:

    Permanent

  • Salary:

    S$5000 - S$7000 per month

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH8347_1603770463

  • Published:

    about 1 month ago

  • Expiry date:

    2020-11-26

  • Consultant:

    #

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

Responsibilities:

  • 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

Requirements

  • 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).