Generis Tek Inc · 4 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.
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
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
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 StageCompany data provided by crunchbase