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Job ID :
61321BR
Location :
US - Connecticut - Guilford
:
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 realworld

impact, and you’ll be supported in achieving your career goals.

Responsibilities:

  • Leads the establishment of compliant and efficient GMP processes related to the design, development and transfer activities of Class I, II and III medical devices and in-vitro diagnostics
  • Provides direction and support for the development and implementation of robust Quality Systems (ISO 13485:2016, cGMP) facility at the Guilford facility
  • Implements cGMP capability expansion for key product lines / technologies including complex systems and companion diagnostics.
  • Provides technical analysis, evaluation and support of Quality Assurance issues affecting global projects, establishing risk mitigation and best practice strategy for resolution
  • Ensures an “inspection ready” state is maintained across all GMP activities and supports site Regulatory Authority inspections and follow up efforts
  • Provides quality specific training and guidance to the organization to correctly identify, define, and quality problems early
  • Subject matter expert when determining clarifications and compliance to written standards, providing additional information for the site to ensure consistent application of quality processes across regulated sites
  • Conducts compliance audits and regulatory body mock inspections
  • Interacts both vertically and horizontally in a way that commands both personal respect and mission acceptance and possess the ability and interpersonal skills to influence all levels of the organization
  • Performs as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I
  • Values (Integrity, Intensity, Involvement and Innovation).
  • Serve as management representative for the Guilford facility
  • Ensure processes needed for quality system are documented
  • Promote awareness of quality regulatory and compliance requirements at the Guilford facility
  • Communicate and keep top management apprised of state of Quality System
  • Minimum travel expected in order to perform the job effectively

Minimum Qualifications:

  • Bachelor’s degree in biotech, science or engineering from accredited college/university or AA plus equivalent experience
  • Minimum of 7+ years related experience in Medical Device or Pharmaceutical Industry
  • Expert knowledge of International Standards ISO 13485 and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR)
  • Broad/well-rounded product and process knowledge
  • Comprehensive knowledge of advanced quality tools, (e.g.: SPC, DOE GR&R, CPK Analysis, etc.)

Preferred Qualifications:

  • Masters of Science in molecular biology, chemistry, biochemistry, microbiology, engineering or related discipline preferred; MBA is also highly desirable
  • Certification by the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE) or Certified
  • Quality Manager (CQMgr)


At Thermo Fisher Scientific, each one of our 65,000 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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