Job Title: Staff QA Engineer
Requisition ID: 54920BR
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.
- Champion the implementation of QMS tools and technologies to enhance compliance to current standards, regulations and corporate requirements.
- Contribute to and execute a strategy for the implementation of QMS initiatives
- Drive initiatives to improve usability of QMS procedures and instructions
- Facilitate improvements of the QMS and provide training in QMS and Good Manufacturing Practices (GMP)
- Manage and improve the CAPA process acting as the site’s CAPA coordinator
- Manage the Internal Audit process.
- Host and follow up on notified body audits
- Project manager/representative on implementation of new eQMS activities
- Manage current paper and eQMS systems
- Create and coordinate creation of key procedures and processes based on feedback, set quality goals and to ensure customer agreement fulfillment
- Support internal functional partners and ensure that all aspects of the QMS are understood, implemented and maintained.
- Work closely with all personnel to ensure that aspects of the QMS are understood, implemented and maintained
- Bachelor’s degree in science or technology field or equivalent three to five year experience
- Working experience with ISO 13485 and with medical device regulations (i.e. MDD 93/42/EEC, FDA 21 CFR Part 820)
- Well organized and structured
- Possess strong analytic and problem solving skills
- Excellent ability to write documents and describe processes and procedures
- Experience in auditing techniques as well as interpreting and transforming requirements to practical implementation
- Attention to detail with good understanding of the big picture.
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