Thermo Fisher Scientific Quality Assurance Engineer III in Fremont, California

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.

How will you make an impact?

The Quality Assurance Engineer III will ensure the effectiveness of processes and procedures in the quality system (e.g. QSM SOPs, Documentation Control, Training, CAPA, etc.). Conduct audits to ensure compliance with QSR, ISO 13485, CMDR and other applicable regulatory requirements. Evaluate quality management processes and propose improvements as appropriate. Lead and coordinate internal audits, supplier audits, supplier qualification and maintenance ensuring compliance with Thermo Fisher approved procedures. Liaison with suppliers to continuously improve processes and mitigate risk.

What will you do?

  • Plan internal and supplier audits to comply with ISO 13485 and 21 CFR part 820, CMDR, IVDD, JPAL, ANVISA, and MDSAP.

  • Develop audit agendas, action plans, and reporting by collaborating with the audit team.

  • Distribute, document and follow through on completion for Notifications of Change received from suppliers to ensure they are adequately assessed for impact and processed in a timely manner.

  • Draft and negotiate the terms of Supplier Change Notifications and Quality Agreements with suppliers.

  • Maintain, retain and track supplier records to ensure compliance with procedural requirements.

  • Assess and approve document, process, and product changes.

  • Report metrics for Management Reviews and Management Meetings.

  • Support management of external, Regulatory, and Customer audits.

  • Provide support to OEM customers, Suppliers, and Internal Customers.

  • Assist with CAPA, Non-Conformances, Change Control, Complaints, and Document Reviews.

  • Other departmental duties as assigned.

How will you get here?

  • Bachelor's degree in Engineering/Life Science discipline with 4-5 years in the medical device or regulated industry.

  • Solid technical understanding of Medical Device auditing.

  • Certified Auditor, CQA or Certified Quality Engineer, CQE. Lead Auditor Certification is a plus.

  • Understanding of FDA 21CFR 820, GMP/QSR, ISO13485, CMDR, IVDD, ANVISA, JPAL, TGA, 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 conflict with diplomacy.

  • Ability to lead small scale projects while working independently.

  • Understanding of Design Control and Validation.

  • Must be able to prepare and present technical data.

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 at 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.