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QA Engineer (Instrument manufacturing)
Singapore - 7 Gul CircleUpdate time: March 12,2020
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Job Description
Operating Hours: Mon-Fri, 8am - 515pm 
Location: Gul Circle (2-way company shuttle bus islandwide available) 
Reporting to: Senior Manager, Quality Control


Responsibilities:
  • Review and approves validation protocols for product and process changes.
  • Review and approve revision changes to DOPs, manufacturing process, components, software and labeling.
  • Ensure failure investigations are performed and well documented for non-conforming materials and products.
  • Establish and maintain database to track root cause, disposition, and cost for non-conforming material.
  • Review customer complaints and analyze data for trends.
  • Identify quality issues through data and trend analysis, work with relevant functions on corrective and preventive actions.
  • Work with management to devise and implement quality strategies and policies.
  • Conduct internal/external audits to assure compliance to quality and regulatory requirements.
  • Supervise technician in the inspection, batch record review and release of products.
  • Provide guidance and training to other employees and QA Technicians as required.


Requirements:
 
Education and Qualifications
  • Degree in Science in Mechanical, Mechatronics or Electrical and Electronic Engineering or equivalent 
Experience
  • Min. 5 years QA experience, preferably in pharmaceutical/biotech industries
  • Working knowledge of ISO 13485 and QSR preferred. 
  • Technical knowledge and experience in PCBAs, electrical & electronic component and able to interpret electrical and electronic circuitry are preferred.
  • Experience in creating, editing and maintaining of Power BI is preferred.
  • Experience in creating, editing and maintaining of VBA is preferred.
  • RA experience in Diagnostic/IVD medical device is preferred.
Other Essential Attributes / Competencies
  • Excellent verbal, written communication and interpersonal skills. 
  • Proficient in the use of quality tools (eg. Trend, regression charts) to present and articulate identified issues.      
  • Self-motivated, results oriented with strong planning and scheduling skills.
  • Applies knowledge to principles and concepts which contributes to the development and enhancement of company processes.
  • Applies unique knowledge and judgment in selecting creative techniques to resolve complex problems. 
  • Open minded for discussion and positively accept feedback.
 
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