Medical Devices Audit Specialist
1 month ago
About UL Solutions
">UL Solutions is a global leader in applied safety science, transforming safety, security and sustainability challenges into opportunities for customers in over 110 countries. Our mission is to advance our safety vision by delivering testing, inspection and certification services, together with software products and advisory offerings, that support our customers' product innovation and business growth.
">Career Overview
">We are seeking an experienced Medical Devices Audit Senior/Senior Auditor to join our Global Medical Devices Auditing Team. This role will involve conducting audits for clients' medical devices quality management systems in compliance with ISO 13485 and other regulatory standards.
">Job Description
">The ideal candidate will have four years' professional experience in the field of healthcare products or related activities, with two years in quality management. They should also have knowledge in Medical Devices legislation, risk management and related devices standard and conformity assessment in MDSAP, ISO 13485, MDD/MDR etc.
">Key Responsibilities:
">- ">
- Conduct regular quality system and technical audits for clients' medical devices quality management systems;">
- Provide timely Audit Reports and customer Corrective and Preventive Action analysis and responses;">
- Perform key Quality Management System audit activities to support safe products to market;">
- Travel domestically and internationally (50-75%) for auditing purposes.">
Requirements:
">- ">
- A minimum of four years' professional experience in the field of healthcare products or related activities;">
- Two years' experience in quality management;">
- Knowledge in Medical Devices legislation, risk management and related devices standard and conformity assessment;">
- Technical experience in active or non-active medical devices, dental devices, or blood & tissue products.">
About the Role
">This is a challenging opportunity for individuals who are passionate about advancing patient safety and improving the quality of medical devices. We offer a competitive salary range of $80,000 - $120,000 per annum, depending on location and experience.
">Benefits
">As a valued member of our team, you will enjoy a comprehensive benefits package, including access to training and development opportunities, flexible working arrangements, and a supportive work environment.
">-
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