Actively participate in product development cycle by reviewing project documentation, participating in product risk assessments, and working closely with the Product Development Team to develop appropriate verification and validation testing requirements.
Assesses overall product risk by facilitating the development of risk management tools such as the risk management report, failure mode and effects analyses (FMEAs), etc.
Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required.
Contributes to the successful completion of Process Validation initiatives by facilitating validation master plans and the qualification activities required to meet validation requirements. May include Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses.
Job requires interaction with cross-functional project team members as well as members of the QA extended team.
Tracking timelines and facilitating the required Quality Engineering deliverables.
Assisting with projects and assuring proper and consistent implementation of the quality engineering tools.
Provide support to other quality groups to assure efficient completion of project requirements.
Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
Provide guidance on the principles of risk management standards as they relate to the new product development activities of mechanical medical devices