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.
- Leads the site CAPA programs
- Provides training for CAPA, root cause analysis and other investigational tools
- Ensures the CAPA system activities are in compliance with all applicable FDA quality system regulations as well as ISO 13485 and ISO 9001 in support of ASR, GPR, and IVD Class I, II and III products
- Provides support for customer and Regulatory audits and inspections
- Performs internal and external audits and supplier surveillance
- Supports day-to-day site-specific quality needs for various, moderately complex products or product families. Examples include responding to non-routine quality complaints (e.g. performance related failures).
- Identifies and implements improvements to processes, systems, and customer related quality issues.
- Collaborates across function, leveraging others’ quality and manufacturing expertise to troubleshoot problems, interpret data, find root cause, determine next steps, and create technical reports
- May provide guidance or direction to other lower-level personnel such as assistance with prioritization and investigations
- Responsible for collecting data, performing moderately complex statistical analyses to investigate trends, provide interpretations, and draw conclusions at the site level
- Knowledge of International Standards ISO-9001, ISO-13485 and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR)
- Site specific software programs (change control notification program, CAPA, etc.).
- Bachelor’s degree in biotech, science or engineering from accredited college/university
- Minimum of 3+ years related experience in Medical Device or Pharmaceutical Industry
- Class II/III IVD complaint handling experience
- Masters of Science in molecular biology, chemistry, biochemistry, microbiology, engineering or related discipline preferred and/or MBA is highly desirable
- Certification by the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE) or Certified Quality Manager (CQMgr)
- Experience with Trackwise, Agile, E1/SAP is a plus
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.