Senior Quality Assurance Engineer

Company: Pivotal Integrated HR Solutions
Location: Pawtucket
Posted on: May 7, 2022

Job Description:

Our client is an international powerhouse in the medical device space that specializes in acute critical care and resuscitation products. They are currently looking for a Quality Assurance Engineer. In this role, you will be responsible for supporting the electrode product and process sustaining activities through the application of Quality engineering skills for medical devices. This position focuses on process, equipment, design verification and validations, working with teams to develop manufacturing and quality processes and define their related tools, resolve validation strategy, and review and approve validations. To be considered for this position, you must have a minimum of four-year degree in a technical discipline and a minimum of 5 years of medical device experience. In addition, you must have knowledge of ISO 13485. Responsibilities: Review and approval of verification and validation protocols and reports Participate in Change Control review and approval activities as required Provide technical guidance to QA and QC personnel Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971 Develop and implement Quality Plans Ensures post-market surveillance reviews are conducted and reports documented according to schedule Participate in CAPA efforts, and apply systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues Provide key quality trending information and data for Management Review and monthly KPI review, as applicable Requirements: Four Year degree, preferably in a technical discipline and minimum 5 years of medical device experience Proficient with Microsoft Office Suite Familiarity with the use of mechanical and electrical test equipment Knowledge of commonly-used concepts, practices, and procedures related to medical device manufacturing Working knowledge of EN ISO 13485, ISO 14971 and FDA QSR for Medical Devices

Keywords: Pivotal Integrated HR Solutions, Pawtucket , Senior Quality Assurance Engineer, Engineering , Pawtucket, Rhode Island