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Job ID :
53565BR
Location :
US - California - Fremont
:
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.


The Quality Specialist II/Lead Auditor will schedule and perform all internal audits and supplier audits to Thermo Fisher approved procedures. This will include auditor training, scheduling, agendas, the audit performance and reporting.


Key Responsibilities:

  • Schedule the internal audits to comply with ISO 13485 and 21 CFR part 820, CMDR and IVDD
  • Train audits to help with the scheduled auditors
  • Instruct audit teams on audit agendas and plans
  • Provide audit agendas, and reports
  • Audit updates for Manage Reviews
  • Perform suppler audits as requested and use a team when deemed necessary
  • Provide an annual audit schedule per SOP
  • Communicate with those being audited in a professional supportive manner
  • Support other areas of the QA staff as needed including CAPA, NCAR, Complaints and document reviews.

Minimum Requirements/Qualifications:

  • Bachelor's degree in Technical/Life Science discipline with two or more years in the medical device industry
  • Solid technical understanding of medical Device auditing
  • Understanding of GMP/QSR, ISO13485/CMDR/CE, ANVISA, JPAL and associated regulatory agencies
  • Excellent communication skills with ability to communicate at all levels within the organization
  • Ability to operate in a high paced environment
  • Able to influence, negotiate and resolve potential sticking points with diplomacy
  • Ability to lead small scale projects
  • Ability to work independently or in a group setting with little direction
  • Understanding of Design Control and Validation
  • Must be able to prepare and present technical data

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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