Job Information
UL, LLC Senior Medical Devices System Auditor in Denmark
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.
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 included regular quality system and technical audits, as well as unannounced CE 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.
University or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering, or other relevant sciences.
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.
Appropriate knowledge in Medical Devices legislation, risk management and related devices standard and conformity assessment in MDSAP, ISO 13485, MDD/MDR etc.
Technical experience in active or non-active medical devices, dental devices, or blood & tissue products, with a focus on medical device processes and products.
Direct experience may include design and development, manufacturing, product testing, quality assurance or medical device supply chain management.
Ability to travel domestically and internationally (50-75%).
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:
Introductory Video call with Talent Acquisition Team
In depth Video call with the Hiring Manager
Technical Assessment with a CMIT Senior Team Member
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A global leader in applied safety science, UL Solutions transforms safety, security, and sustainability challenges into opportunities for customers in more than 100 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 Certification Marks serve as a recognized symbol of trust in our customers’ products and reflect 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.
From the adoption of electrification to the enablement of 5G and new mobility, we collectively look toward new frontiers, working for a safer world. Our science is your advantage.
Mission: Working for a safer world
UL LLC has been and will continue to be an equal opportunity employer. To assure full implementation of this equal employment policy, we will take steps to assure that:
Persons are recruited, hired, assigned and promoted without regard to race, color, age, sex or gender, sexual orientation, gender identity, gender expression, transgender status, religion, creed, national origin, ethnicity, citizenship, ancestry, disability, genetic information, military or veteran status, pregnancy, marital or familial status, or any other protected category under applicable law.