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Reporting into the General manager, The Director of Quality & Regulatory will direct the organisation's Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits and regulatory submissions.
The Sr. Product Quality Engineer is responsible for ensuring the high quality and reliability of the company's products through comprehensive testing, analysis, and improvement initiatives. They lead efforts to identify and resolve quality issues, implement quality management systems, and drive continuous improvement throughout the product development life cycle.
Making sure componenet and finished products and proccesses are approved. Leading MRB activities.
The Manufacturing Engineer will join a small team, reporting into the Director of Electro-Mechanical Operations, helping to support diverse product lines. In this role you will utilize lean and six sigma skills and work on the manufacturing floor.
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.
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.
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