| Title: Principal Quality Assurance/Validation Engineer
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| Location: Piscataway, NJ
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| Job Type: Direct Hire
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| Compensation: $100,000.00 to $120,000.00 per Year
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| Reference Code: 942414-AQG
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| Description: Our client is seeking a highly skilled/ motivated Quality Assurance/Validation Engineer to ensure medical systems are compliant with regulatory requirements. This person will provide quality engineering support to Hardware Development Team; review and approve Design Inputs for adherence to Quality System Regulation Design Controls; and work with clinicians to gather critical customer input and validation of prototypes. This person will convert all design inputs into a Design Input Document and Traceability Matrix; create risk assessments for Scanners as per ISO 14971; and create failure modes and effects analysis for design, manufacturing and clinical aspects of device. This person will also combine all risk assessments; use all risk determinations for overall device to drive Clinical and Design Validation; and write Design Validation Protocols. This person will ensure risks are identified and validated properly with correct confidence and reliability; write Design Verification Protocols where all outputs are compared to Design Inputs; and attend Design Review Meetings. This person will ensure meeting minutes are recorded with all action items and objections; assign corrective actions; and escalate items to leadership when required. This person will also create quality system documentation in accordance with Design Controls and QSR; establish and refine documentation control and regulatory processes for instrument development engineering and be responsible for regulatory compliance; and write Software Validation Protocols and Reports for embedded software in digital pathology-scanning devices. This person will provide Quality engineering support for clinical trials; write and help execute manufacturing process validations; and write Validation Reports. Candidates must to successfully transfer QA design into manufacturing. This role will ensure measurement instrumentation is calibrated and traceable to NIST.
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| Requirements: A BS in an Engineering/Life Sciences discipline or equivalent with 8+ years of Quality Engineering (Design Controls) in a Medical Device including embedded software of the device is required. 5+ years of experience in a Medical Device Manufacturing environment are required. Candidates must have experience in interfacing with regulatory agencies during FDA or ISO-type audits. Candidates must be software proficient in Microsoft Windows and Microsoft Office; must have experience in General Quality Systems software; and must be able to perform statistical analysis of test and clinical results in order to determine statistical validity or the results. Experience with multiple Medical Device releases, specifically software centric capital equipment, is required.
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