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Process Development Engineer - Design Control

Location
Fremont, CA

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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 You Will Make an Impact?
In this role you will have the opportunity to partner with Research and Development and act as a subject matter expert for new product development (NPD) for cutting edge technology including liquid chromatography, and mass spectrometry (LCMS). When you join a market leader such as Thermo Fisher Scientific, your career goals are unlimited offering you a future of upward mobility, and exposure to other clinical assays in our Clinical Diagnostic Division (i.e. immunology, drugs of abuse, toxicology, etc.)
What You Will Do?
Evaluate, develop, and implement Quality System Feedback Processes to achieve goals in accordance with established QSR, ISO, CMDR and IVDD Regulations.
Provide guidance to the R&D Core Team, and advice to process owners on defined Quality Systems procedures and policies.
Provide support to R&D in creating Design History Files.
Coordinate the completion of batch record review for final review and QA release.
Develop and implement Quality System procedures.
Provide Quality System Regulations Training, as needed.
How Yo
u Will Get Here?
B.S. degree in technical field or equivalent experience.
5 years of experience within the medical device industry including NPD, internal/external auditing, and project management experience.
Understand the design control process (design planning, process validation and verification).
Knowledge of FDA and ISO 13485 regulations.
Knowledge of Quality System Regulation (QSR), ISO, CMDR, IVDD Regulations.
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 mission—enabling 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.
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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