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Job ID :
54920BR
Location :
US - New York - Rochester
:
Job Description

Key Responsibilities:

  • Champion the implementation of QMS tools and technologies to enhance compliance to current standards, regulations and Corporate requirements.
  • Contribute to and execute a strategy for the implementation of QMS initiatives
  • Drive initiatives to improve usability of QMS procedures and instructions
  • Facilitate improvements of the QMS and provide training in QMS and Good Manufacturing Practices (GMP)
  • Manage and improve the CAPA process acting as the site’s CAPA coordinator
  • Manage the Internal Audit process.
  • Host and follow up on notified body audits
  • Project manager/representative on implementation of new eQMS activities
  • Manage current paper and eQMS systems
  • Create and coordinate creation of key procedures and processes based on feedback, set quality goals and to ensure customer agreement fulfillment
  • Support internal functional partners and ensure that all aspects of the QMS are understood, implemented and maintained.
  • Work closely with all personnel to ensure that aspects of the QMS are understood, implemented and maintained.

    Minimum Requirements/Qualifications:

  • Bachelor’s degree in science or technology field or equivalent three to five year experience
  • Working experience with ISO 13485 and with medical device regulations (i.e. MDD 93/42/EEC, FDA 21 CFR Part 820)
  • Well organized and structured
  • Posses strong analytic and problem solving skills
  • Excellent ability to write documents and describe processes and procedures
  • Experience in auditing techniques as well as interpreting and transforming requirements to practical implementation
  • Attention to detail with good understanding of the big picture.



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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