COMPANY OVERVIEW: Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life. POSITION OVERVIEW: This positon will support manufacturing quality operations in a dynamic, fast-paced, medical device-manufacturing environment. This environment includes the manufacture, inspection, and test of devices for design verification, design validation, and commercial production. RESPONSIBILITIES: - Working under the direction of the Quality Manager, ensure all product, processes, and components are within specifications. - This position may also serve as a member on collaborative cross-functional teams, to support new product development efforts, commercial production, material-related design changes, and manufacturing and process changes, risk management activities, and other compliance projects. - Work in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016. - Lead the Device History Records (DHR) review and approval process. - Lead nonconformance reports (NCR) and CAPA investigations. - Lead the development and implementation of PFMEAs and control plans. - Lead process and equipment validation activities (IQ, OQ, PQ/PV, TMV). - Lead manufacturing and quality system improvements. - Lead customer feedback process and investigations. - Author Engineering Change Orders (CO); support CO implementation tasks - Use experience with engineering and technology to ensure compliance with applicable standards and regulations. - Position requires daily contact with members of Production, Engineering, Materials, and Quality departments. - Routine contact with design authority and customers; occasional contact with auditors QUALIFICATIONS AND SKILLS: - 5+ years of experience related to the manufacturing of medical devices in a QMS environment while being in a Quality Control or Engineering role - Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 is required - Experience with Microsoft Office software (Word, Outlook, Excel) required - Experience participating in internal and external audits - Strong project management, prioritization and leadership skills are required - Must be able to manage multiple priorities - Performing statistical data analysis using Minitab or equivalent - Presenting and leading meetings with an audience of peers and senior management level - Use critical thinking and deductive reasoning to make risk based decisions - Knowledge and comprehensive understanding of CAPAs, root cause analysis, and the 8D method - Excellent oral communication and technical writing skills - High level of attention to detail and accuracy EDUCATION: Bachelor’s degree or equivalent experience in Manufacturing, Mechanical or related engineering / life sciences related discipline.