Thermo Fisher Scientific Quality Engineer III 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.
Our Bedford, MA site is expanding and 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. . If you believe in working the right way for the rig right reason join our growing team today!
How will you make an impact?
As a Quality Engineer III you'll work to improve the quality of operations and drive 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?
Assigned to processes and projects of moderate to high complexity, perform compliance assessments, make decisions regarding quality and regulatory requirements; ensures adherence to current regulations with little dependence on others
Team participant assigned to projects related to quality initiatives and compliance improvements
Facilitate risk assessments, FMEAs and pFMEAs for new product introduction, and take appropriate actions during quality oversight activities to ensure adequate controls in relation to the level of product quality, safety and business risks
Manage Supplier Change Evaluations, Internal Change Evaluations, Product Quality Reviews, Customer Notifications, Field Action activities
Provide quality support for issues requiring impact assessment, root cause analysis, identification of appropriate corrective actions, implementation of CAPA plan and monitoring of effectiveness
Perform statistical analysis/trend problem reporting data to support the site (e.g. yield improvements, CAPA, complaint and scrap reduction)
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) or other Lean/Continuous Improvement methodologies
Quality tools e.g. FMEA, Risk Analysis
Global Systems e.g. Trackwise, AGILE, E1/SAP
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.
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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