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Location :
US - California - San Jose
Job Description

Senior Quality Engineer

Position Summary:

Reporting to the Sr. Manager/Director of Product Quality, the Sr. Quality Engineer will be an integral part of the QARA team with the primary responsibilities that include:

  • Planning & driving various product quality improvement activities and/or projects,
  • Supporting supplier qualification and development activities,
  • Reviewing Device History Records prior to shipment,
  • Providing QA/QS support and guidance to functional groups including but not limited to Manufacturing, Engineering, R&D, Purchasing, Customer Service, Product Support, etc., and
  • Playing a key role in the New Product Development/Introduction process.

Essential Functions:

  • Use key product/process metrics to evaluate process effectiveness, identify improvement opportunities/best practices, and drive continuous quality improvement activities.
  • Lead cross-functional teams in the execution and reporting of continuous improvement projects with a focus on overall warranty/defect reduction.
  • Partner with Supplier Quality Engineering/Manufacturing Engineering/QA on supplier qualification/development activities.
  • Partner with Supplier Quality Engineering/Manufacturing Engineering/QA on planning and implementation of various Dock-to-Stock initiatives.
  • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
  • Work closely with production line and ensure all necessary controls are fully implemented to be compliant with ISO13485/9001 and FDA QSR requirements.
  • Review assigned Device History Records (DHR’s) and associated documents prior to shipment to ensure that all documents and specifications are met.
  • Provide support to Operations including the review and approval of manufacturing work instructions, deviation requests, and nonconforming material reports, and Engineering Change Orders.
  • Conduct internal and supplier audits (as assigned).
  • Serve as a core team member on NPD projects to ensure compliance with design controls per ISO 9001/13485, and FDA QSR.
  • Participate in Design Reviews and identify possible improvements based on relevant risk analysis, past manufacturing/warranty experience, and Marketing/Customers’ specifications/requirements for products.
  • Participate in internal PPI (Process Kaizen) activities (as assigned).

Minimum Requirements/Qualifications:

  • Bachelor’s degree in EE, ME, Chemistry, or other relevant fields required.
  • A minimum of 10 years of QA experience.
  • Hands-on experience working with various Mass Spectrometry instruments is preferred.
  • Ideal candidate must possess considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD and ISO 13485/9001.
  • Certified ASQ CQE/CQA preferred.
  • Experience with Phase Gate Review Process.
  • Extensive experience working with Contract Manufacturers is a plus
  • Proficient in use of statistical analysis and methods.
  • Must be team oriented and have excellent interpersonal skills.
  • Must have excellent written and verbal communication skills with ability to clearly articulate requirements.
  • Must be practical and flexible to effectively work with individuals from multiple functional groups.

This position has not been approved for Relocation Assistance.

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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