Quality Engineer
My3Tech Inc
Software Quality Engineer (SQE)Number of Positions: 1Duration: 12 monthsWork Location: Onsite - Hybrid (3 days a week)Start Date: JanuaryProject Details:Scope of Work: Serve as SQE, working independently on supporting warehouse informationReview test plans and requirement documentsPerform approvals on documents to meet applicable regulations (21 CFR)Support validation on warehouse systemsSupport equipment decommissioningCollaborate on testing plans and approvalsWork with supplier quality and commercial quality teamsDay-to-Day Responsibilities: Review test plans and requirement documentsPerform approvals to meet regulations (21 CFR)Support equipment decommissioningCollaborate on testing plans and approvalsWork with supplier quality and commercial quality teamsRequirements:CSV experience in medical devices and 21 CFR (3-5 years, mid-level)GAMP 5 experienceExperience in medical device manufacturing and operationsBonus Requirements:GAMP 5 certificationOnsite (local resource)CSQE certificationAuditor certificationAdditional Requirements:Soft Skills/Company Culture: Team environment, collaboration, independent communicationEducation: Engineering/science/technical bachelor's degreeCertifications: GAMP 5, Audit, CSQE (all are a plus)Experience Level: Mid (3-5 years)Industry Experience: Required in medical devices
Vacancy posted 5 days ago
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