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Quality Engineer III, Design Assurance

Company: Thermo Fisher Scientific
Location: Fremont
Posted on: October 12, 2017

Job Description:

Job Description

When youre part of the team at Employer, youll 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 youll be supported in achieving your career goals.


Job Summary:

The Quality Engineer III, Design Assurance will provide quality assurance support for new products in development. They are responsible for the definition, implementation and improvement of quality related practices and procedures. They also provide technical guidance and measurement methodologies in addition to assisting in problem solving.


Position Responsibilities:

  • Serve as Core team member on New Product Development projects to ensure compliance with Design Controls per ISO 13485 and FDA QSR.The ideal candidate should have hands-on experience with drafting risk management and design control documents.
  • 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 SOPs) 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.
  • 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.

Minimum Qualification/Requirements:

  • Bachelor's degree in Engineering/Life Science or equivalent discipline.
  • Minimum 5 years of related experience in Medical Device / Biologics/ IVD manufacturing or an advanced degree and 2-3 years of direct related experience.
  • Experience working with New Product Introduction (NPI) and solid knowledge working with design control and risk assessment.
  • Experience determining sample sizes based upon statistical analysis is a plus.
  • Process control experience is highly preferred.
  • Hands on validation (IQOQPQ) experience for equipment/process is ideal.

At Employer, each one of our 55,000 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 Employer dir=ltr>


Employer 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.


*IND-SDG



Employer 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.

Keywords: Thermo Fisher Scientific, Sacramento, Quality Engineer III, Design Assurance, Engineering, Fremont , California

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