Principal Quality Assurance / Validation Engineer

Our client is seeking a highly skilled/motivated Quality Assurance/Validation Engineer to ensure medical systems are compliant with regulatory requirements. Responsibilities include: * Provide quality engineering support to the Hardware Development Team * Review and approve Design Inputs for adherence to Quality System Regulation Design Controls * Work with clinicians to gather critical customer input and validation of prototypes * Convert all design inputs into a Design Input Document and Traceability Matrix * Create risk assessments for Scanners as per ISO 14971 * Create failure modes and effects analysis for design, manufacturing, and clinical aspects of device * Combine all risk assessments * Use all risk determinations for overall device to drive Clinical and Design Validation * Write Design Validation Protocols * Ensure risks are identified and validated properly with correct confidence and reliability * Write Design Verification Protocols where all outputs are compared to Design Inputs * Attend Design Review Meetings * Ensure meeting minutes are recorded with all action items and objections * Assign corrective actions * Escalate items to leadership when required * 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 * Write Software Validation Protocols and Reports for embedded software in digital pathology-scanning devices * Provide Quality engineering support for clinical trials * Write and help execute manufacturing process validations and write Validation Reports * Successfully transfer QA design into manufacturing * Ensure measurement instrumentation is calibrated and traceable to NIST Requirements: The successful applicant will possess the following experience and skills: * BS degree in an Engineering/Life Sciences discipline or equivalent * 8+ years of Quality Engineering (Design Controls) in a Medical Device including embedded software of the device * 5+ years of experience in a Medical Device Manufacturing environment * Experience in interfacing with regulatory agencies during FDA or ISO-type audits * Software proficient in Microsoft Windows and Microsoft Office * Experience in General Quality Systems software * Ability 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

Please refer to job code 1696AQG950694P199 when responding to this ad.

Category:	Engineering
	> Other Engineering
Location:	Piscataway, NJ
County:	Middlesex County
ZIP Code:	08854
Pay Rate:	Open
Job Terms:	full time
Company:	Kforce Inc.
Phone:	email only please
Fax:	email only please