Quality Engineer II, Design Assurance

Location
Fremont, CA
Salary
Competitive
Posted
June 12 2017
Ref
50294BR
Position Type
Full Time
Job Description

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.


Position Summary:

The Quality Engineer II will act as core team member for new products in development as well as interact with various levels internally and externally to plan and execute changes to process or product. The Quality Engineer II will participate in facilitating design control and risk management training to the site. The incumbent will be responsible for providing guidance on process/equipment/product validations by actively participating in the project meetings, and reviewing/approving required documentation.


Key Responsibilities:

  • 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 activities.
  • Serve as Core team member on New Product Development projects to ensure compliance with design controls per ISO 13485 and FDA QSR.
  • 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.
  • 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 (Chemical Engineering, Chemistry, Bio-Chemistry).
  • Minimum 2 to 5 years of related experience in Medical Device / Biologics/ IVD manufacturing.
  • Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD and ISO 13485.

At Thermo Fisher Scientific, each one of our 50,000 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. 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.



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.