Position Description

Senior Quality Engineer (Medical Electronics Manufacturing)
Job Code 18961
Division GMP TECHNOLOGIES (S) PTE LTD (EA Licence:11C3793)
Job Placement Location Singapore
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Position Summary:

  • Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies requirements.
  • Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of products.
  • Participate on internal, inter-facility and vendor/supplier quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, FDA and ISO requirements.

 

Responsibilities:

  • 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.
  • 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.

 

Requirements:

  • Bachelor degree qualified
  • Minimum 3-4 years of relevant experience related to manufacturing of small electro/mechanical devices, preferably in a quality assurance or test-related capacity.
  • 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.
  • Some project management experience nice to have

 

 

We regret that only shortlisted candidates will be notified.

 

GMP Technologies (S) Pte Ltd   |   EA Licence: 11C3793   | EA Personnel:  Tan Wai Peng  |   Registration No: R1104671

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