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The Quality Engineer (medical device manufacturing) plays a key role in ensuring product and process quality through all phases of development, validation, and production, in compliance with ISO 13485 and FDA regulations. This individual will lead root cause investigations, support design controls, and drive continuous improvement initiatives in a fast-paced, innovation-focused environment.
This Product Development Quality Engineer role involves ensuring adherence to strict quality and regulatory standards throughout product and process lifecycles, leading quality initiatives, and driving continuous improvement. Responsibilities also include technical leadership, mentorship, and collaboration with internal and external stakeholders to guarantee the development of high-quality, compliant medical devices
The Manufacturing Engineer focuses on integrating new projects into production and enhancing existing manufacturing processes to improve efficiency, quality, and ergonomics. It requires strong technical problem-solving, the ability to manage projects independently, and occasional customer interaction to clarify technical requirements.
The Quality Engineer, medical device manufacturing, will work to improve the quality of products and processes while operating in a culture highly receptive to quality. You will have the opportunity to support and provide guidance to ensure adherence to processes and procedures that maintain safety, efficacy, and compliance with applicable standards and regulations onsite at out Hudson, NH facility.
The ideal project engineer candidate will have 3-5 years of experience supporting construction projects-specifically mid-rise (6-story) and mixed-use developments. You'll play a key role in coordinating submittals, RFIs, and construction documents while working closely with seasoned project managers and superintendents.
The Manufacturing Engineer will sit on a small team reporting into the Manufacturing Engineering Manager. In this role you will get to work autonomously, wearing many hats, supporting the manufacturing of surgical medical devices.
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