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The Sustaining Engineering Manager will be responsible for ensuring that all technical aspects of product design and manufacturing are managed with internal and external members and partners.
This role will be responsible for managing a team of engineers and technicians focused on sustaining engineering activities, including product improvements, cost reduction initiatives, quality enhancements, and regulatory compliance.
In this role you will be focused on ensuring the quality and regulatory compliance of product designs. Responsibilities may include overseeing design control processes, conducting risk assessments, and collaborating with cross-functional teams to develop and implement quality management systems.
In this role you will be overseeing and implementing quality control processes to ensure compliance with regulatory standards and maintain product excellence. Responsibilities include developing and implementing quality management systems, conducting risk assessments, and collaborating with cross-functional teams to address quality issues and drive continuous improvement.
Serve as a quality ambassador to improve awareness, visibility and communication on quality initiatives and to support assigned departmental, functional, site, divisional and corporate quality goals and priorities within the specialty products vision care of the client.
The Quality Engineer position with my client involves ensuring compliance with medical device regulations, particularly ISO 13485 and FDA standards, to maintain the highest quality standards in organ preservation and transplantation technologies. The role requires proactive problem-solving, collaboration with cross-functional teams, and a commitment to continuous improvement to uphold my clients' mission of advancing organ transplantation technology.
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