Senior Quality Engineer

3 weeks ago

New York, United States Comrise Full time

A leading medical device manufacturing company in Solon,OH is seeking a Senior Quality Engineer Sr. Quality Engineer - Long term contract- Benefits offered Position summary: In this role you will support quality system and engineering activities. This includes creating and updating quality system procedures; developing and implementing quality and manufacturing standards and equipment for processing raw materials and/or components for repaired, refurbished, or returned products. This role is essential in enabling the Service Depot to effectively diagnose, repair, or refurbish medical devices or their components. Additionally, this role drives improvements, enhancing Quality, Cost, Speed of repair processes with implementation of lean manufacturing principles in Service business. Essential duties and responsibilities: Responsible for overall service quality management of the site. Responsible for the quality system of the site including maintaining compliance to regulatory requirements and certifications (ISO 13485) and supporting audits. Initiate and complete change cycle for updated QMS documents including change implementation and training. Engage and interface in internal and external audits providing subject matter expertise. Act as internal Auditor of Company QMS Work closely with business functions to ensure compliance and high-quality performance of Service processes. Engage in the development and improvement of Service processes for existing products. Support day to day service operations and addressing line requests by acting as Subject Matter Expert for Quality and Manufacturing standards. Support the creation and maintenance of service procedures for incoming analysis, trouble shooting, repair, and inspection of products returned from customer. Own, maintain and improve Service line(s) layout, setup, configuration, and fixturing. Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary. Support continuous improvement initiatives with suppliers and in-house teams to improve Quality, reduce cost, and increase efficiency and effectiveness of Service processes. Collaborates with cross functional teams and suppliers to address quality issues and align practices. Support analysis and resolution of Service-related complaints and field actions Own internal and supplier non-conformances and manage the timely disposition and closure of NCRs/NCs Communicate/collaborate with suppliers regarding non-conformances, escalating supplier corrective actions requested as required. Own or support identified internal CAPAs and manage to timely root cause investigation, implementation, and closure. Assess and implement internal and supplier proposed changes. Performs PPAP activities for supplier changes. Plan and execute equipment/process validation and reporting. Applies statistical methods of analysis and process control to current Service operations. Light work: Exerting up to 40 pounds of force occasionally and/or up to 20 pounds of force frequently and/or a negligible amount of force constantly to move objects Qualifications & experience: 5 + years of engineering experience in medical device environment. Must have experience creating and updating quality management system (QMS) documents. Must have knowledge of applicable domestic and international regulations and quality system standards – FDA QSR, MDD, ISO3485, ISO9001, etc. Ability to work independently from discovery to implementation. Ability to work with remote teams as needed. Excellent communication skills, time management and organization sills with attention to detail. Previous experience in a regulated environment and understanding of Medical Device manufacturing processes is desirable.

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