Clinical Quality Engineer

Thermo Fisher Scientific Inc. Carlsbad , CA 92008

Posted 3 months ago

Job Description:

ThermoFisher is at the forefront of the global response toCOVID-19. We are working with governments,agencies, industry partners and researchersglobally to ensure priority access to instruments,consumables, safety supplies and other productsto address the outbreak. This key role will play a valuable part in our efforts.

Now is an exciting time to join our Genetic Sciences business, our industry leading scale means unparalleled commercial reach,unique customer access and a global footprint. Ourbroad customer base, fromresearch to clinical tocommercial production means you can have a broad andmeaningful impact. All while working in an environment where you will besupported,valued and rewarded for your performance. Join the team with unmatched depth ofcapabilities and help our customers solve some of the world's toughest challengesfrom the fight against COVID-19 to Zika to many others.

How will you make an impact?

The Clinical Quality Engineer will serve as a tactical quality professional in ensuring compliance on internal work performed to develop clinical products that are in compliance with Good Clinical Practices (GCP's), Good Laboratory Practices (GLP's), and other applicable standards. Lead and/or participate in quality improvement project teams across a variety of operational departments to identify and implement significant improvements to quality systems and business processes. Partner with the Research and Development, Design Quality, Site Quality and Regulatory to ensure standardization across Genetic Testing Solutions Business Unit.

What will you do ?

  • Partner with R&D, Design Quality, Site Quality and Regulatory to develop, implement, maintain and continually assess a Clinical quality assurance and quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements.

  • Review and recommend appropriate corrective action to ensure consistency with the Clinical quality assurance function and the quality management system

  • Maintain current knowledge base of regulations, corporate policies and standards to ensure that the Clinical quality assurance function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements.

  • Identify risks and assumptions in plans, anticipate problems and plan for contingencies.

  • Contribute to the development and implementation of GCP-related Quality Management System processes.

How will you get here ?

  • Proven ability to effectively develop, communicate, and gain support cross functionally and with a wide range of stakeholders.

  • Excellent understanding of regulations and standards such as; CFR 820, ISO 13485, ISO 9001, or similar standards/regulations.

  • Excellent judgment and creative problem-solving skills, excellent interpersonal skills, organizational skills, written and oral communication skills


  • Bachelor's Degree is required (Biological sciences or related degree); advanced degree is a plus

Knowledge Skills and Abilities

  • 5-7+ years of experience developing, implementing, or maintaining a Quality Management system in an FDA regulated industry (drugs, biologics, medical devices, or related industry)

  • Ability to work independently as individual contributor

  • Demonstrated skills in project management

  • Energetic, flexible, collaborative and proactive

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Clinical Quality Engineer

Thermo Fisher Scientific Inc.