Position Description

Senior Quality Engineer (Global Medical Devices MNC) @ East
Job Code 18938
Division GMP TECHNOLOGIES (S) PTE LTD (EA Licence:11C3793)
Job Placement Location Singapore
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  • Global Medical Devices MNC
  • Working Location: East



  • Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.
  • Evaluate product/material discrepancies. (PRB/MRB) on time, and implement corrective actions accordant.
  • Establish mechanism to evaluate, measure, monitor and/or quality in our products.
  • Provide check and balance to manufacturing/system changes submitted by manufacturing Engineers through evaluation/approval of Engineering change request/orders. Ensure update of manufacturing processes in order to reflect quality concepts and specification requirements.
  • Support other Quality Engineer improvement and quality activities as needed.
  • May provide guidance and assistance to less experienced engineer (eg. Quality Engineer I)
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Ensure that processes comply, with a high confidence level, the tolerances stated on the product specification and drawings.
  • Apply statistical tools in order to assure that processes comply with the specifications.
  • Conduct failure investigations in order to initiate, stimulate, and assign corrective action.  Issue written reports and update, accordingly.
  • Review and analyze quality trends with the manufacturing team. Analyze data based on trends, recommend actions for process, equipment and system improvement.
  • Work on product transfers activities and actively participate in product qualifications and validations of equipment and processes.
  • Perform risk assessment activities with reliability for product quality risks


  • Min Bachelor’s Degree in Engineering qualification is required
  • At least 4 years of relevant experience related to manufacturing of small electro/mechanical devices, preferably in a quality assurance or test-related capacity.
  • Highly preferrable with project transfer/validation experiences in healthcare industry
  • Understanding of Statistical Process Controls is an added advantage
  • Proficient in use of Minitab software is preferred.
  • Knowledge of ISO13485 and FDA requirements (21CFR Part820) is preferred.
  • Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
  • May have practical knowledge of project management


To apply, please visit to www.gmprecruit.com and search for Job Reference: 18938

To find out more about this opportunity, please contact Alexandra at: alexandra@gmprecruit.com

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Alexandra Calingo | Registration No: R1101491

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