| 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: 949538-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.
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
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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
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