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The Lead Systems Engineer will oversee all project details through hardware and software initiatives through R&D developments.
This role focuses on supporting product development and manufacturing processes to ensure compliance with medical device quality standards. Key responsibilities include working with cross-functional teams to maintain compliance with FDA and ISO regulations, overseeing design controls, risk management, and verification/validation activities, and ensuring that product designs meet stringent quality and safety standards.
The Quality Engineer role at the client involves developing and maintaining quality systems, conducting root cause analyses, and ensuring compliance with standards like ISO9001 and AS9100. The position supports continuous improvement initiatives, supplier audits, and cross-functional collaboration to enhance product reliability and manufacturing processes.
The Quality Engineer ensures product quality by developing and implementing robust testing procedures, analyzing defects, and driving continuous improvement initiatives. This role involves close collaboration with engineering and manufacturing teams to maintain compliance with industry standards and customer expectations.
The Quality Engineer (medical device manufacturing) will lead efforts to ensure product compliance with medical device regulations and quality standards, focusing on design controls, risk management, and validation activities at our Southborough, MA facility. They will collaborate cross-functionally to drive continuous improvement, resolve complex quality issues, and support the seamless transition from design to manufacturing.
The Quality Engineer ensures product quality and compliance by implementing and monitoring quality systems, conducting audits, and working on the production floor. They collaborate with cross-functional teams to improve processes, ensure regulatory compliance, and support continuous improvement initiatives.
As a CNC Machining/Manufacturing Engineer, you will provide hands-on engineering support, focusing on continuous improvement, process implementation, and advanced troubleshooting. This role will also involve integrating new products, processes, and equipment to drive growth in a dynamic, high-tech manufacturing environment.
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