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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.
The Design Quality Engineer role involves ensuring the quality and compliance of medical device designs, particularly in organ preservation and transplantation. Candidates will apply expertise in quality management systems and regulatory standards to drive product safety and efficacy in this critical healthcare field.
Making sure componenet and finished products and proccesses are approved. Leading MRB activities.
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.
Step into the role of Senior Quality Assurance Specialist, where you'll leverage your extensive experience to ensure adherence to the highest quality standards and regulatory compliance within the dynamic field of medical devices. As a key player, you'll spearhead initiatives aimed at driving innovation and advancing patient care through meticulous attention to detail and a commitment to excellence.
The Senior Quality Engineer will enhance awareness, visibility, and communication regarding quality initiatives while supporting departmental, functional, and corporate quality goals within a medical device manufacturing space. The ideal candidate will possess a robust understanding of FDA/ISO 13485 Quality System requirements, GxP standards, and other pertinent regulations.
Your role as a Quality ambassador in the Specialty Products division is centered on boosting awareness, visibility, and communication regarding quality, with a particular focus on aligning these efforts with the division's unique needs and objectives.
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