For The Candidates

(908)  North Jersey 

Principal Quality Engineer

Essential Responsibilities

We are looking for highly skilled, highly motivated team players, wanting to make a real difference and thrive to exceed our customer expectations. Our development philosophy is to assemble small agile teams of about 5-7 people, consisting of individuals with strong skill sets and a team player attitude.

Our quality and regulatory philosophy is to develop strong and simple quality systems that are compliant with US and WW regulatory requirements. We believe in creating an honest and transparent environment that will allow any regulatory agency that audits to instantly discover the robustness of the quality system.

• Provide direct quality engineering support to the Hardware Development Team.
• Review and approve Design Inputs for adherence to Quality System Regulation Design Controls requirements. Work with clinicians at selected partner sites 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 the Scanner as per ISO 14971. Create failure modes and effects analysis for design, manufacturing and clinical aspects of the device. Combine all risk assessments into one master risk assessment. Use the risk determinations for the overall device to drive the Clinical and Design Validation Requirements.
• Write Design Validation Protocols as per Quality System Regulations. Ensure that all risks are identified and all validated properly with the correct confidence and reliability.
• Write Design Verification Protocols where all outputs are compared to the Design Inputs.
• Insure the correct statistical rational is selected for all forms of testing.
• Provide quality-engineering support for Design Reviews. Attend Design Review Meetings. Ensure meeting minutes are recorded including all action items and objections. Assign corrective actions in the CAPA system in order to address all action items. Escalate any items to the leadership team that cannot be resolved.
• Create all quality system documentation in support of the development team in accordance with Design Controls and the QSR.
• Establish and refine documentation control and regulatory processes for instrument development engineering and be responsible for regulatory compliance.
• Establish a development tollgate processes needed for timely product delivery and be accountable for adherence to such timelines.
• Must be able to write Software Validation Protocols and Reports for embedded software in the digital pathology-scanning device.
• Must be able to provide software quality engineering support to Piscataway and Pittsburgh as required.
• Must coordinate with Quality Engineering in Pittsburgh in order to maintain the overall Device Master Records, quality records and documentation into one consolidated file.
• Create and maintain Design History Files.
• Create and maintain the Device Master Record.
• Quality engineering support for clinical trials.
• Write and help execute all manufacturing process validations. Write Validation Reports.
• Must be able to perform a successful design transfer into manufacturing. Must be able to perform the required process validations for the manufacturing of the software centric device.
• Provide support to help create and maintain all quality systems.
• Provide support to resolve customer complaints (CAPA’s).
• Ensure that all measurement instrumentation is calibrated and traceable to NIST.
• Perform supplier audits and aid in vendor selection as required.
• Responsible for setting up the productions and process controls system for the manufacturing of the device. This includes setting up the Device History Records to show compliance with the Device Master Record requirements.
• Responsible for meeting all Design Control requirements for the hardware side of the device.

Qualifications/Requirements

• BS in an Engineering/Life Sciences discipline or equivalent.
• 8+ years Quality Engineering (Design Controls) in a Medical Device including embedded software of the device. Environment 5+ years experience in Medical Device Manufacturing.
• Experience in interfacing with regulatory agencies during FDA- or ISO-type audits.
• Must be software proficient in Microsoft Windows and Microsoft Office. Must have experience in General Quality Systems software. Must be able to perform statistical analysis of test and clinical results in order to determine statistical validity or the results.

Desired Characteristics

• Experience with multiple Medical Device releases, specifically software centric capital equipment