Job Title: Engineer II, Quality AssuranceRequisition ID: 174483BRLocation/Division: South San Francisco, CA
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 Engineer II, Quality Assurance plays a crucial role in assuring processes and compliance meet ISO 13485, 9001, and FDA standards. This role is the conduit across numerous departments and teams, inspiring continuous improvement in quality and efficiency and analyzing, reviewing and interpreting information to lead the way in collaborative and compelling solutions.What will you do?
- Develop, implement, and validate process methodology to ISO 13485, 9001 and FDA standards. Setup, revising and updating Standard Operating Procedures, system, or processes.
- Constantly review procedures and processes and work closely with key internal partners to provide recommendations for improvements. Develop procedures, work instructions, guidance, best practice protocol.
- Ensure that the lab, manufacturing and development processes are compliant with Quality System and EHS requirements.
- Assignments include areas such as leading product transfer, troubleshooting, non-conformance evaluation, customer complaint handling investigations, CAPA, process & system enhancement and drive sustaining activities to meet QA goals
- Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO audits (internal , customer and registrar audits).
- Works on problems of diverse scope where analysis of data requires review and interpretation of identifiable factors. Demonstrates solid judgment in selecting methods and techniques for obtaining solutions.
- Establishes working relationships across functions. Employs internal working relationships to influence business objectives.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilitiesHow will you get here?Minimum Qualifications
Knowledge, Skills, Abilities
- Bachelor's Degree in Science, Engineering, or Business or equivalent schooling and work experience
- Some Quality Assurance experience in an ISO 9001 or 1345 work environment
- Proven analytical skills
- Project Management experience preferred
- Quality Assurance,
- ISO 9001, 1345, and FDA standards
- Good judgement
At Thermo Fisher Scientific, each one of our 80,000 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.Accessibility/Disability Access
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