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Job ID :
57094BR
Location :
US - California - Fremont
:
Job Description

The Thermo Scientific Controls business is a group of passionate individuals committed to changing the way medicine is practiced. This role is part of a dynamic R&D team developing IVD products that improve the quality of patient testing at the cutting edge of technology and medicine.
The ideal candidate will be a team player who is passionate about delivering simple, effective, customer-focused products.

The Technical Writer III, R&D will incorporate design control and product development experience to launch robust, innovative products for diagnostics. All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

Responsibilities:

  • Provides support to R&D in creating Design History Files (Master Control and Agile) for new and sustaining product development, (how we develop a product, design transfer )including but not limited to preparation of design control documentation, process and test method validation protocols/reports, risk analyses, manufacturing and QC documentation
  • Solicit, align, and incorporate feedback from diverse stakeholders
  • Participate on Project Core Teams as a contributing member and assist with audits as required
  • Responsible for evaluating, developing and implementing Quality System Feedback to achieve goals in accordance with established QSR, ISO, CMDR and IVDD Regulations
  • Takes a critical thinking approach to assess processes, and identifies and executes on opportunities for streamlining and improvement


Minimum Qualifications:

  • Bachelor’s degree in scientific related field AND 5 years of industry experience; OR master’s science degree in scientific related field AND 3 year of industry experience
  • Strong knowledge of cGMP and Quality Systems
  • Excellent written and verbal communication skills
  • Demonstrated ability to think strategically
  • Advanced Microsoft Word and Excel skills
  • Willingness to take on new challenges and be flexible and adaptable in a complex, matrixed environment
  • Highly collaborative with the ability to work within a diverse team and contribute to a supportive, positive work environment, both within the team and in the greater site-wide community
  • Strong track record of working cross-functionally


Preferred Qualifications:

  • Experience in In Vitro Diagnostics or medical device industry
  • Participation in launch of at least one medical device product under design control
  • Experience with working on OEM projects and with OEM customer quality departments
  • Experience and understanding of Design Control
  • Demonstrated project management experience, with ability to manage multiple activities and tasks



At Thermo Fisher Scientific, each one of our 50,000 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.




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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