Careers at ThermoFisher Scientific

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Job Description

Essential duties and responsibilities

  • Review and approves validation protocols for product and process changes
  • Review and approve revision changes to DOPs, manufacturing processes, components, software and labelling
  • 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 materials
  • Review customer complaints and analyze data for trends
  • Review and supervise incoming and outgoing inspections
  • 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 polices
  • 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

Qualifications and Experiences

  • Bachelor degree in Electrical and Electronic Engineering preferred
  • Minimum 2 years QA experience, preferably in pharmaceutical / biotech / semiconductor industries
  • Technical knowledge and experience in PCBAs, electrical and electronic components and having the ability to interpret electrical and electronic circuitry
  • Working knowledge of ISO 13485 and QSR preferred
  • Excellent verbal and written communications skills required
  • Proficient in the use of quality tools (e.g. 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 contribute to the development and enhancement of company processes

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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