Sr. Quality Engineer - Medical Device

Job Description Summary Reporting into the Quality Department, this role has responsibility for Quality related actions in support of New Product Development (NPD, Design Quality).  Works collaboratively with project team members to develop and manage project plans.  Champion design control and risk management activities for assigned projects. Evaluate risk and verification implications for purposed post launch design changes. Continuously improve Design Control procedures and maintain procedural compliance. Essential Functions Supports new product development and implementation of new products  via development of an overall quality plan, including needed inspection, test, and audit procedures; identification of needed reliability testing; identification, procurement, and maintenance of needed engineering test equipment; and support of process/product validation.  Responsible for development and release of engineering design documentation. Develops and administers an inspection, test, and/or audit program to ensure that incoming, in-process, and finished products meet functional specifications and quality standards.  Ensures completeness, accuracy, and testability of product requirements (Control plans, MSA, datasheets, inspection instructions, etc). Assist in preparation for regulatory submissions and Defend Design Control elements during internal and external audits.       Leads the review, disposition, and corrective action activities associated with discrepant components, materials, sub-assemblies and finished products associated new products.      Leads the review of field returns and concerns, assists in the analysis and the development of corrective actions; ensures proper documentation of complaint analysis and failure investigation; monitors and reports during new product development. Evaluate all post launch purposed design changes to determine impact on risk level, verification and/or validation testing. Maintain Risk Management Files for site in compliance with procedures. Support CAPA and HHE process as required.  Lead continuous improvement activities including contributing to system level procedural requirements/updates as needed. Provide training, leadership and mentorship to teams and junior QEs      REQUIREMENTS   Travel - Domestic. Up to 10%   Education - BS in Engineering or technically related field         Licenses/Certifications -  CQE and Six Sigma certification preferred   Experience -  5+ years Quality Engineering experience in Medical Device Industry     R25654
Salary Range: NA
Minimum Qualification
5 - 7 years

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