Quality Engineer

Experis is the global leader in professional resourcing and project-based workforce solutions. We accelerate organizations' growth by intensely attracting, assessing, and placing specialized expertise in IT, Finance, Engineering, and Healthcare to precisely deliver in-demand talent for mission-critical positions, enhancing the competitiveness of the organizations and people we serve.

The Senior Quality Engineer will ensure that all requirements of the quality system are met for the assigned product and partners and also ensure regulatory compliance throughout the organization.

- Provide quality engineer support to Product Development Teams. - Review and approve Design Inputs for adherence to Quality System Regulation Design Controls requirements. - Ensure design outputs are well documented. - Create risk assessments as per ISO 14971. - Create failure models and effects analysis for design, manufacturing and clinical aspects of the device. - Use the risk determinations of the overall device to drive the Clinical Design Validation Requirements. - Write Design Verification Protocols where all outputs are compared to the Design Inputs. - 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. - Ensure the correct statistical rationale 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 at the team level. - Create all quality system documentation in support of the development team in accordance with Design Controls, the QSR and other applicable regulations. - Create and maintain Design History Files. - Create and maintain the Device Master Record. - Provide Quality Engineer support for clinical trials. - Write and help execute all manufacturing process validations. Write Validation reports. - Provide support and ensure successful design transfer to 3rd party contract manufacturing. - Provide support for Supplier Management Program. Able to set up and execute Supplier Qualification, perform audits, and write reports. - Provide support to help create and maintain all aspects of the quality system. - Compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Pharma Management System. - Manage the customer complaint and corrective and preventive action system for your assigned products. - Ensure that all measurement instrumentation is calibrated and traceable to NIST. - 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 to ensure compliance to all Design Control requirements.

- In-vitro diagnostics experience is very helpful but not required. Familiarity with regulatory and compliance requirements for diagnostics tests. - 5 plus years of Quality Engineering (Product Development/Design Controls) in an IVD/Medical Device environment, Medical Device manufacturing experience is also valuable. - Preferred knowledge and competency in: 21 CFR 800 to 1299, ISO 13485, ISO 14971, ISO 15189, CLIA regulations. Contract Manufacturing, ASQ CQE/CQA Certification. **Education:** * BS Degree in the Sciences or Engineering