Quality Assurance Engineer
About the Job
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.
Location/Division Specific Information
The BioProduction Division is one of the fastest growing businesses in the company, supporting developers and manufacturers of biological-based therapeutics and vaccines. Our site in Bedford, MA continues to grow.
How will you make an impact?
You’ll be responsible for batch record review and disposition of product. You’ll drive to improve the quality of operations and to improve and maintain a quality culture with a goal of consistency. You will support and provide guidance to the adherence of in-house processes and procedures in order to maintain safety according to EH&S requirements and compliance to ISO 13485 standards.
What will you do?
- Provide guidance and information from a quality perspective to help drive New Product launches towards successful outcomes.
- Performs statistical analysis to track report data to support the site (e.g. CAPA, Right First Time)
- Monitors for quality related issues and coordinates resolutions.
- Review of documents such as, but not limited to, Batch Records and Quality Procedures.
- Contribute to continual process improvement by participating in Kaizens, Gemba tours and site projects.
- Works directly with investigation teams on critical quality issues
- Support activities within the Quality Management System as required
How will you get here?
Education and Experience
- Bachelor’s degree from accredited college/university or equivalent experience. Preferred Science or Engineering Degree
- Minimum of 5 years of relevant Quality/manufacturing/engineering experience in a regulated industry
Knowledge, Skills and Abilities
- Knowledge of Quality standards (e.g. ISO 13485)
- Global Systems (e.g. Trackwise, AGILE, E1,SAP)
- Ability to work independently or as part of a team, self- motivated, adaptable
- Excellent communication and Attention to Detail
- Minor traveling to local sites to support operations as part of the quality assurance team is required.
At Thermo Fisher Scientific, each one of our 75,000 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.