Quality Engineer jobs in United States
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Generis Tek Inc · 9 hours ago

Quality Engineer

Generis Tek Inc is seeking a Quality Engineer for a contract role in Saint Paul, MN. The position requires a candidate with medical device quality experience to support software development, manufacturing, operations, and engineering teams, ensuring compliance with FDA and ISO regulations.

Information Technology & Services
Hiring Manager
Megan Bell
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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

Qualification

Medical Device Quality experienceFDA/ISO regulations knowledgeHazard Analysis activitiesSDLC document reviewRamp up quickly

Required

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

Company

Generis Tek Inc

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Generís Tek is an elite IT staffing firm headquartered in Chicago, IL offering long-term, short-term, temporary-to-permanent and direct placement staffing.

Funding

Current Stage
Growth Stage
Company data provided by crunchbase