Quality Engineer

SEDAASanta Clara, CA
22d$50,000 - $70,000Onsite

About The Position

100 percent onsite. Selected Candidates will start ASAP after screenings have cleared. St. Paul : 1225 Old Highway 8 NW 100 percent onsit 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

Number of Employees

11-50 employees

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