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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.
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.
As the Quality Engineer you will gain hands on experience in medical device development, focusing on manual testing, design controls, sterilization, and transit testing. You will collaborate closely with mechanical engineers and cross functional teams to ensure compliance with FDA regulations and ISO 13485 standards.
The Product Development Quality Engineer ensures the highest quality standards for advanced micromanufactured components used in medical devices, focusing on compliance, process improvement, and defect prevention. The role involves collaborating with cross-functional teams to develop and validate robust quality systems, driving innovation in medical device manufacturing.
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.
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