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Thermo Fisher Scientific Quality Engineer II in Bedford, Massachusetts

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location: Bedford, MA - Wiggins Ave

How will you make an impact?

As a Quality Engineer II you are expected to take the initiative to improve the quality of operations and to improve and maintain a quality culture. You will be responsible for supporting internal, customer, registrar and corporate audits related to our ISO13485 Quality Management System and be a member of our Internal Audit team. 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?

  • Collaborate across functions, leveraging quality expertise to troubleshoot problems, interpret data, and determine next steps

  • Assist with the maintenance of ISO registration and the internal audit program

  • Support customer and corporate audits including scheduling, documentation support and audit response

  • Manage the master internal and external audit schedules and quality audit files. Ensure audits are tracked and performed on time.

  • Conduct and support internal audit activities as needed.

  • Collaborate with other site functions to drive process improvements and resolve issues

  • Investigate quality problems

  • Ensure proper use of quality systems and processes

  • Perform training on Quality procedures

  • Create, review and revise quality policies and procedures

  • Collect and analyze quality data

  • Participate, as needed, on new product teams

  • Perform other duties and cross training as assigned

How will you get here?

  • Bachelor’s degree from accredited college/university

  • 3+ years experience in a manufacturing or quality environment

  • Auditing experience preferred

  • Experience working in a team environment

Knowledge, Skills, Abilities:

  • Knowledge of Quality standards and Good Documentation Practices (e.g. ISO 13485)

  • Strong written and oral communication skills

  • Strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines

  • Ability to develop credibility and positive professional relationships with subordinates, peers and upper management

  • Detail oriented

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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