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Thermo Fisher Scientific Engineer II, QA in Bedford, Massachusetts

Job Title: Quality Engineer II

Reports to: Quality Manager

Location: Bedford, MA

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?

A QA Engineer II is responsible for, but not limited to, batch record review and disposition of product. Personnel are expected to take the initiative 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. Minor traveling is required to support operations as part of the quality assurance team.

Responsibilities:

  • 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

Minimum Qualifications:

  • 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

Preferred Qualifications:

  • 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

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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