Quality Systems Auditor/Engineer III

Location
Fremont, CA
Salary
Competitive
Posted
August 31 2017
Ref
54369BR
Position Type
Full Time
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 Systems Auditor/Engineer III will schedule and perform all internal audits and supplier audits as needed in compliance with 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, IVDD, JPAL, Anvisa, MDSAP
  • Train auditors to help with the scheduled audits
  • Instruct audit teams on audit agendas and plans
  • Provide audit agendas, and reports
  • Report audit metrics for Management 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, Nonconformances, Change Control, Complaints and document reviews
  • Other departmental duties as assigned

Minimum Requirements/Qualifications:

  • Bachelor's degree in Technical/Life Science discipline with five (5) 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

At Thermo Fisher Scientific, each one of our 55,000 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.