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Thermo Fisher Scientific Quality Assurance Engineer in Bedford, Massachusetts

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.

Now is an exciting time to join our Quality team, a team dedicated to ensuring our customers receive the products they need to achieve their scientific goals - quickly, reliably and safely. Our Bedford, MA site is expanding and ramping up to support the fight against COVID-19. If you believe in working the right way for the rig right reason join our growing team today!

How will you make an impact?

This is a newly created role that will focus on investigations, risk assessments and other critical quality initiatives supporting the growth of the business and the site expansion.

What will you do?

  • You'll work on processes and projects, perform compliance assessments, make decisions regarding quality and regulatory requirements while ensuring adherence to current regulations.

  • With a focus on continuous improvement, you'll work on projects related to quality initiatives and compliance improvements, product transfers, new product introductions, facility expansions

  • Provide Quality support for issues requiring impact assessment, root cause analysis, identification of appropriate corrective actions, implementation of CAPA plan and monitoring of effectiveness

  • Facilitate risk assessments and take appropriate actions during quality oversight activities to ensure adequate controls in relation to the level of product quality, safety and business risks

  • Perform statistical analysis/trend problem reporting data to support the site (e.g. yield improvements, CAPA, complaint and scrap reduction)

  • Provide CAPA, RCA and QMS training to internal groups

  • Routinely interact with internal and external customers at various organizational levels; supports internal and external audits

  • Support other activities within the Quality Management System as required.

How will you get there?

  • 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

  • Demonstrated team leadership

  • Knowledge of Quality standards (e.g. ISO 13485)

  • Knowledge of PPI (Practical Process Improvement), Lean Manufacturing or other Continuous Improvement tools/methodologies

  • Experience with Quality tools such as FMEA and/or Risk Analysis strongly preferred

  • Knowledge of Global Systems such as Trackwise, AGILE and/or E1/SAP preferred

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. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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