Quality Engineer
SEDAA•Santa Clara, CA
•Onsite
About The Position
The need is for 2 Quality Engineers. One more Senior and one Mid‑Level. Selected Candidates will start ASAP after screenings have cleared. Must come with Medical Device Quality experience and be able to start contributing quickly. Training will be provided on Abbott systems, but foundational medical device knowledge is required.
Requirements
- Medical Device Quality experience (Ops or Manufacturing)
- Strong working knowledge of FDA/ISO regulations (13485, 14971, etc.)
- Ability to ramp up quickly
- 3–5 years experience
Responsibilities
- Support Quality for software development, manufacturing, operations, and engineering teams
- Review/approve SDLC documents
- Lead Hazard Analysis activities
- Assist with SOPs, Work Instructions, and occasional training
- Occasionally write/execute test protocols and reports
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
