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

Education

  • 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

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Staff Design Compliance Quality Engineer

Thermo Fisher Scientific Inc.

Posted 2 weeks ago

VIEW JOBS 10/9/2020 12:00:00 AM 2021-01-07T00:00 Job Description When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals. Location/Division Specific Information We are searching for Scientists or Engineers in Southern California. How will you make an impact? Here is your opportunity to link your work experience with a job that allows you to be involved on projects developing real new world solutions. Your unique skillset is needed. If you have a Quality background in NPI (new product introduction) in IVD or Medical Devices, you are needed. If you have a statistics background, you are sought. If you have ASQ certifications, you certainly are in high consideration. And if you have experience with Software, you would be highly valued. What will you do? * Provide guidance for product development under Design Controls: User and Product requirements, Functional Specifications, Design Verification, Design Validation, Test Method Validation, Risk Management, and Design Reviews. * Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards * Work closely with New Product Introduction teams to meet compliance requirements on schedule * Participate on team projects and assignments, facilitating or leading sub-teams as necessary. The Staff Design Compliance Quality Engineer will be responsible for supporting New Product Introduction (NPI) programs by providing input to the development teams and authoring or approving Design Controls deliverables. This Design Assurance position is also responsible for providing guidance and coaching for post market product sustaining activities, such as design changes and CAPAs. How will you get here? Education Bachelor's degree in a Technical or Engineering discipline required. Experience * Experience in instrumentation and software product development is a plus. * Experience implementing Design for Compliance and training programs * Experience in the Lab / IVD / Medical Device field is preferred. * Seven (or more) years of progressive professional experience in Design Compliance or Quality Engineering role. Knowledge, Skills, Abilities * Strong knowledge of Design Controls, Risk Management, and regulatory guidelines and their application * Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization. * Ability to act quickly and decisively. At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Apply today! http://jobs.thermofisher.com 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. * EVAMOPS2020 *GTSDouble Thermo Fisher Scientific Inc. Carlsbad CA

Clinical Quality Engineer

Thermo Fisher Scientific Inc.