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Job ID :
54301BR
Location :
US - California - Santa Clara
:
Job Description

Job Title: QA Engineer III
Requisition ID: 54301BR

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


Responsibilities:

Responsible for performing a wide variety of activities to ensure compliance with the QMS and applicable regularity requirements by facilitating CAPAs, reviewing/analyzing data, working on product development teams, supporting product sustaining issues, developing procedures, and reviewing changes to documentation. Additional responsibilities include supporting customer quality by analyzing complaints and communicating issues with cross functional team for timely resolution. Additionally, this position will be responsible for administering, maintaining and providing general oversight of employee training using the company's Learning Management System (LMS).


  • Execute procedures and processes to support the Quality Management System
  • Participate in the preparation of audits by potential partners, customers and regulatory agencies
  • Develop/review QA system SOPs to ensure compliance, as required
  • Review customer complaints
  • Review device history record, special instructions, Planned/Unplanned Deviation, rework instructions, QC test data.
  • Initiate Deviation and Non-Conforming Material Report.
  • Perform Change Order process, Non-Conforming Material process, investigation and closure.
  • Assures compliance to in-house and/or external specifications and standards, such as cGMPs and ISO regulations (documentation review, internal audits)
  • Provide administrative and project support in the area of quality.
  • Assist Quality manager in establishing, implementing, maintaining, and improving the quality management system
  • Create and maintain company quality documentation
  • Participates in process and operation improvement opportunities
  • Responds to internal and external inquiries
  • Administering, maintaining and providing general oversight of employee training using the company's Learning Management System (LMS
  • Complies with company quality management systems, policies and procedures
  • Provides mentorship, if applicable
  • Additional duties/responsibilities according to business need


Minimum Qualifications:
  • Associate Degree or equivalent related experience
  • Bachelor’s in Life Science Discipline is preferred
  • 5-8 years of experience
  • Working knowledge of FDA QSRs and ISO 13485

Preferred Qualifications:
  • Bachelor’s in Life Science Discipline is preferred
  • Experience facilitating CAPAs, reviewing/analyzing data, working on product development teams, and Training
  • Certified Quality Engineer (CQE),
  • Certified Quality Auditor (CQA)


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.


*IND-LSG




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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