San Jose CA: Quality Engineer (232770)

Life Sciences & Technology | Validation

Job Description:

Our client is looking for an experienced Quality Engineer to assist with a dual role in respect to manufacturing and design & development processes. There are ongoing projects that require attention in various areas. The first part of this project will involve closure of a facility where current design & development programs are being closed out, customers have been notified, as well as the last few prototypes being built out with intent of completing this scope of work by June. Main responsibilities will include closure of R&D projects, design control, design & development documentation, and site transfers.

The second half of the project will support manufacturing processes for one of their main customers, while the project build-out takes place within the next month. Responsibilities will involve on-the-floor support of manufacturing processes, ensure documentation requirements are being met, address inspection issues, work on NCR’s, overseeing potential re-works, confirm proper training is taking place, and overseeing product builds in Phase III & Phase IV development. The consultant for this project will interface with the production supervisor to provide quality support, inspection check-ins, identity defects, ensure corrective actions are in place, and as-needed expertise for decisions on products.

This resource will require exception critical thinking when issues arise to identify & mitigate potential risks. Must be familiar with innerworkings of disposition plans (when something needs to be reworked, repurposed, etc.). There will be heavy cross-functional involvement with manufacturing engineers, production supervisor, customers, and other appropriate point of contacts.

Required skills:

Design & Development, Design Control, Quality Engineering, Risk Management, NCR’s, Manufacturing processes & documentation, Quality Systems
Class III Medical Devices (catheter or cardiovascular preferred)
Working knowledge of GMP, ISO 13485, 21 CFR Part 820

Bonus/Nice to have:

MasterControl or IFS

San Jose CA: Quality Engineer (232770)


About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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