Engineer, Quality

1 week ago


Singapore SG ENDOSCOPY PTE. LTD. Full time
Job Descriptions

  • Supports medical device development & manufacturing operations including but not limited to
  • QMS/DMR development;
  • Root cause investigations for corrective actions;
  • Implementation of corrective actions;
  • Analyse quality metrics for corrective and preventive actions: and
  • Change records and assurance of proper record control.
  • Develops test protocols and reports for the validation and/or revalidation of equipment, processes, test methods, and computer systems.
  • Develops sampling plans, determines sample sizes, and perform data analysis using various statistical tools including but not limited to regression analysis, ttest, ANOVA, and process capability indices.
  • Collaborates with manufacturing engineering, production, purchasing, and quality assurance functions to drive process excellence.
  • Technical liaison to external medical device customers.
  • Coordinate Internal Audit / Supplier Audit Programme
  • Technical reviewer of engineering changes related to product specifications, process parameters, methods and equipment.
  • Performs as technical writer responsible for the development of test protocols, test reports, work instructions, and standard operating procedures.
  • Assist in maintaining certification and regulatory compliance to ISO 13485, QSR, Medical Device Directive Requirements and any regulatory standards as applicable.
  • Supports Quality Assurance in the review, analysis, and reports on process and product performance to management.
  • Conduct new employees' orientation (NEO) training for Quality Management System and 6S for newly joined employees.
  • Other adhoc tasks assigned by immediate supervisor.

Requirement:

  • Minimum Degree in Mechanical/ Mechatronic Engineering.

Experience:

  • Minimum 35 years relevant experience as a Quality Professional, preferably in ISO 13485 environment.
  • Good understanding in the implementation of QMS (ISO 13485), Quality Assurance and Quality Control methodology.
  • Regulatory experience in GMP(Good Manufacturing Practice) procedures

Skills:

  • ISO 13485 Internal Auditor Trained
  • Sixsigma trained with strong engineering fundamentals.
  • Strong attention to details and able to work under tight deadlines.
  • Ability to multitask, prioritize tasks and quickly adjust in a rapidly changing environment

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