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 Senior Quality Specialist will ensure compliance to the Corrective and Preventative Action (CAPA) process, and to applicable Medical Device and IVD regulations/requirements by serving as a subject matter expert to different cross-functional groups. Provide guidance to CAPA owners, and work closely with CAPA Review Board (CRB) members in the administration of CAPA activities and the rigorous assessment of CAPA documentation.
What will you do?
- Provide continuous and rigorous assessment of CAPA activities and documentation to assure compliance with the CAPA process, FDA regulations, ISO 13485, and Medical Device and IVD requirements through the review of CAPA records at critical phases.
- Provide guidance, support and mentorship to CAPA owners regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools.
- Support CRB and senior leadership with metrics and reporting on critical aspects regarding the health of the CAPA process.
- Participate and coordinate CRB activities and perform the Senior CAPA Specialist role throughout the site.
- Support the continuous improvement of CAPA procedures, CAPA software, and CAPA training programs.
- Provide guidance in interpreting governmental regulations, agency guidelines, Thermo Fisher internal policies in general, and specific to CAPA to assure compliance.
- Support internal and external audits and inspections for CAPA records and processes and other roles as needed.
- Generate quality metrics for senior management.
- Perform other related duties as assigned.
How will you get here?
- Bachelor's degree and 8 years of direct related experience in Quality or a combination of education and experience to perform at this level
- Experience working with CAPA, complaints, and nonconformances
- Experience in medical device, pharmaceutical, IVD and/or a comparable regulated environment
- Influence-management skills; ability to work constructively across all functions of the organization as well as with external customers, notified bodies, regulatory agencies, and competent authorities
- CAPA documentation systems experience (e.g. CATSWeb, MasterControl, Trackwise, etc.)
- Experience reviewing CAPA, complaint, nonconformance documentation (preferably as an independent reviewer)
- Strong written and verbal communication skills
- Ability to educate people in the CAPA program
- Experience with quality tools and process improvement techniques
- Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
- Project management skills
- Strong analytical and decision making skills
- Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and CAPA requirements in general
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!
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.
Associated topics: performance test, prevention, quality assurance, quality assurance lead, software quality, software quality assurance, software quality engineer, software quality assurance engineer, test, test engineer