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Staff Quality Engineer

Expired Job

Thermo Fisher Scientific Inc. Fremont , CA 94537

Posted 4 months ago

Job ID :

Location :

US - California - Fremont


Job Description

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

The Staff Quality Engineer will provide quality assurance support for new products in development, as well as on market products. Provide guidance and mentorship to junior QEs. Lead cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements. Provide hands on experience with drafting risk management and design control documents. Define and implement improvement of quality related practices and procedures. Provide technical guidance and measurement methodologies in addition to assisting in problem solving.

What will you do?

  • Serve as Core team member on New Product Development/design change projects to ensure compliance with Design Controls per ISO 13485 and FDA QSR.

  • Develop and/or implement quality planning techniques in a medical design/manufacturing environment for new product introductions.

  • Use statistical and risk management techniques for design and manufacturing and medical device industries.

  • Participate in Design Reviews and identify improvements based on relevant risk analysis, past manufacturing experience, and Marketing/Customers' specifications/requirements for products.

  • Establish and participate in supplier qualification/development activities to ensure that products meet design and manufacturing requirements as part of Design Transfer.

  • Advise and evaluate product verification/validation as well as equipment, process and material qualification/validation activities.

  • Evaluate and implement protocols and methods (including SOP's) to ensure that incoming material and manufactured products are compliant with internal requirements as well as to standards/regulations for worldwide distribution.

  • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.

  • Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement.

  • Lead cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements, scrap reduction and supplier quality improvement.

  • Provide guidance and mentorship to Junior Quality Engineers.

  • Active participation and support of the internal audit process.

  • Drive corrective, preventive, and closure actions for project issues related to quality and/or test non-conformance.

  • Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.

How will you get here?

  • Bachelor's degree with a preference for Life Science discipline. Advanced degree a plus.

  • Minimum 8 years of related experience in Medical Device / Biologics/ IVD manufacturing or an advanced degree and 5 years of direct related experience; or, advanced degree with 6 years of direct related experience.

  • Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD, Design Control requirements, and ISO 13485.

  • Hands on experience with equipment/process validations is ideal.

  • Experience with sample size determination using statistical technique and process control is preferred but not required.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

Apply today!

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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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Staff Quality Engineer

Expired Job

Thermo Fisher Scientific Inc.