Quality Operations Specialist at Merrimack Manufacturing

Job DescriptionJob DescriptionCOMPANY 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 position will support manufacturing quality operations in a dynamic, fast-paced, medical device manufacturing environment. This environment includes the manufacture, inspection, and testing of devices for process validation and commercial production.RESPONSIBILITIES:Working under the direction of Quality Engineers support, drive, and coordinate final inspection and acceptance of medical devices.Support quality engineers in processing nonconformances, deviations, and rework authorizations by gathering data, updating logs, or drafting documentation.Perform Device History Record (DHR) reviews for completeness, accuracy, and compliance to internal and regulatory requirements.Identify and document errors or missing information in DHRs and coordinate with production or quality teams for timely correction. Work cooperatively with team members on commercial production lines to support quality requirements and projects.Provide administrative and technical support for change orders, training records, and CAPA follow-up as assigned.May perform inspections for components, materials, devices and documents. Position requires daily contact with members of Production, Engineering, Materials, and Quality departments and occasional contact with auditors and customersQUALIFICATIONS AND SKILLS:2 + years of experience in occupation related to Manufacturing or Quality Control of medical devices.Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 is preferred. Experience with Microsoft Office software (Word, Outlook, Excel) required.Self-starter and independent individual with strong organizational, time management and communication skills.Ability to drive assigned tasks to closureMust be able to manage multiple priorities. Use critical thinking and deductive reasoning to make risk based decisions.EDUCATION: Associate degree or equivalent experience in Manufacturing, Quality, Mechanical or related engineering / life sciences related discipline. Powered by JazzHR9T0WpdBkQe