Senior Project Engineer - Medical Device

JOB DESCRIPTION
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• Support contract review / agenda setting for quality management system audits.
• Support regular quality system and technical audits, including CE, UKCA unannounced audits.
• Provide timely Audit Reports and customer Corrective and Preventive Action analysis and responses.
• Subject to training and qualification milestones, perform key Quality Management System audit activities to support safe products to market.
• Support Competent Authority activities on as needed basis e.g. Competent Authority audits of UL.
• Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.
• Provide guidance and support to customers as required. Participate in client training and customer forums.
• National/International travel is required (50% to 75%).
• Product Reviewer (per MDR) competencies and applications also welcomed.
• Performs other duties as directed.

QUALIFICATIONS

• Bachelor's degree required. Prefer Graduate Science Degree in Pharma Sciences, Engineering, Technology, or similar
• At Least four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the area of quality management.
• Solid knowledge of Manufacturing methods for Medical Devices.
• Appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents;
• Appropriate knowledge and experience of risk management and related device standards and guidance documents;
• Appropriate knowledge of quality management systems and related standards and guidance documents;
• Appropriate knowledge and experience of the conformity assessment procedures in the listed programs (MDSAP, ISO13485, MDD/MDR, etc), in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those audits;
• Training in auditing techniques enabling them to challenge quality management systems;
• The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
• Active or not active medical devices codes

ABOUT US
A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers' product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers' products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.