Sr. Quality Assurance Engineer

MicroAire Surgical Instruments LLC As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best. The Senior Quality Engineer will lead and participate in projects and activities associated with MicroAire’s quality system. Partner with cross-functional teams to continuously improve the Quality Management System (QMS) and its execution. Apply risk-based criteria to prioritize actions related to CAPA and post-marketing quality systems. Is responsible for multiple projects in order to ensure compliance with the company's quality systems and standards while enabling speed to market and attainment of company goals. Leads Quality Engineering activities for the development of new medical devices. Serves on New Product Development Projects as a team member by providing quality engineering expertise including design verification, design validation, risk analysis, risk management reports, equipment installation qualification, process operational qualification, process performance qualification, packaging validation, sterilization validation and supplier quality. + Essential Duties and Responsibilities Works with R&D and Manufacturing Engineers to support implementation of new products by developing quality and testing plans. Supports the new product development process as a team member. Answers any questions or concerns with device quality / reliability within the new product development team. Participates in establishing and reviewing specifications/requirements for components, products and processes as part of new product development. Provides feedback on manufacturing-related documentation for regulatory submissions and product release. Participates in teams responsible for the procurement and installation, operational and performance qualification (IQ/OQ/PQ) of manufacturing equipment/processes. Develops Quality Plans for quality systems that adhere to the QMS. Leads and participates in quality metrics reviews; identifying weaknesses and risks associated with MicroAire products and tracking the mitigation of those issues throughout the corrective action process. Works with Suppliers to maintain high quality levels of incoming production materials. Supports Supplier Quality by providing reliability input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability requirements are met. Participates in quality audits of suppliers. Partners with cross-functional departments as required, mentoring and aiding teams in performing complaint investigations and CAPA activities. Partners with suppliers and supply chain as required to improve quality, cost, and delivery from suppliers. Works with incoming inspection to ensure adequate and robust quality inspections. Performs gauge R&R, capability analysis, etc as required. Utilizes standard statistical analysis and problem-solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc. Supports quality system maintenance by identifying and correcting deficiencies in procedures and practices. Leads and supports CAPA teams in the analysis and resolution of product quality issues. Leads and implements QMS software solutions aimed at continuously improving the QMS. Performs other job-related duties and activities as assigned. + Education and Experience Education: Bachelor's degree in engineering or science discipline Experience: Six years of Quality or Manufacturing Engineering experience required, supplier quality engineer experience preferred Medical device experience is highly desirable; regulated industry experience required Fa…

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