Senior Medical Devices System Auditor

Job Description

Our Global Medical Devices Auditing Team is growing and is looking for its next team member!

Our Auditing teams deliver effective medical management system audits to meet each client's unique requirements. Whether assessments are to be conducted on-site or in the field, we independently evaluate established criteria to help our customers identify and close implementation gaps. In addition, we offer follow-up services that include audits to continuously verify the conformity of UL certified medical device management systems.

After an intensive and customized training provided by experienced colleagues, you will be responsible for independently conducting audits at our customers in Medical Devices industry all over Europe.

Responsibilities

1. Perform audits for clients' medical devices quality management systems in compliance with the requirements of ISO 13485 and other regulatory standards such as MDSAP, MDD, MDR and UKCA. These audits include regular quality system and technical audits, as well as unannounced CE audits.
2. Provide timely Audit Reports and customer Corrective and Preventive Action analysis and responses.
3. Subject to training and qualification milestones, perform key Quality Management System audit activities to support safe products to market.
4. Support Competent Authority activities on an as-needed basis e.g., Competent Authority audits of UL.
5. Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.
6. Provide guidance and support to customers as required. Participate in client training and customer forums.

1. University or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering, or other relevant sciences.
2. 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 quality management.
3. Appropriate knowledge in Medical Devices legislation, risk management and related devices standard and conformity assessment in MDSAP, ISO 13485, MDD/MDR etc.
4. Technical experience in active or non-active medical devices, dental devices, or blood & tissue products, with a focus on medical device processes and products.
5. Direct experience may include design and development, manufacturing, product testing, quality assurance or medical device supply chain management.
6. Ability to travel domestically and internationally (50-75%). This position can be located in the UK, central/northern Europe or any metropolitan area near a major airport.

For UL it is important to be efficient during our recruitment process in respect of anyone's time. For this role this is the defined interview process:

1. Introductory Video call with Talent Acquisition Team
2. In-depth Video call with the Hiring Manager
3. Technical Assessment with a CMIT Senior Team Member

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.

About the Team

UL Solutions helps medical device companies navigate the complex and rigorous global regulatory landscape that is specific to these industries. Medical devices must be safe and effective in order to be approved in each global market. We help companies determine the appropriate regulatory strategies for their global markets by coordinating testing, assessments, studies, audits and submissions required by global regulatory authorities. We advise our customers about the changing standards, regulations and develop resources and tools to help our customers make more effective decisions.