ROM Technologies, Inc. · 1 week ago

Quality Engineer

Brookfield, CT

Full-time

Onsite

Mid Level

3+ years exp

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Health CareMedical Device

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Responsibilities

Design and review project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.

Work with the Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs.

Audit, monitor, and witness test processes for compliance with requirements and keeping a watchful eye for risk opportunities.

Ability to participate in gathering of QA Engineering metrics gathering and compiling for higher level review.

Communicate regularly with Manufacturing and Test counterparts, and proactively engage in issue resolution.

Other responsibilities as assigned.

Qualification

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Medical device industry experience21 CFR Part 820Quality management systemsManufacturing processesRisk management (ISO 14971)Technical writingDesign history file documentationSpreadsheet utilizationPivot tablesData analysisProblem solvingAssertivenessMulti-taskingPrioritizationFast-paced environmentInterpersonal skillsCommunication skillsDesign VerificationValidation