MedTech Executive Search LLC · 1 week ago

Quality Engineer

Greater Philadelphia

Full-time

Onsite

Senior Level

3+ years exp

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Health CareMedical

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Responsibilities

Support the design and document change control review and approval processes. Manage document and record control.

Support supplier selection, qualification, and monitoring activities to ensure supply chain readiness and on-going performance. Troubleshoot and lead corrective actions relating to supplier performance

Responsible for supporting QMS deliverables, including but not limited to: customer complaints, field safety corrections/removals, risk analysis, NCMR, CAPA.

Perform quality inspection of incoming product (receiving, in-process, finished goods) to ensure compliance to specifications

Qualification

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Medical Device QualityFDA Quality System RegulationsISO 13485ISO 14971Risk ManagementAnalyticalCritical ThinkingInterpersonal CommunicationVerbal CommunicationWritten CommunicationStartup ExperienceAdaptability

Required

Minimum of 3 years working within a Medical Device quality organization

Bachelor’s Degree or Higher (Engineering or life science degree preferred), or equivalent experience

Knowledge and experience with FDA Quality System Regulations, ISO 13485 Quality System Standard, ISO 14971 Risk Management, and other applicable regulations

Strong analytical, critical thinking, and interpersonal communication skills

Excellent verbal and written communication skills