At UL, we know why we come to work.
Thousands of us around the world wake up every day with a common purpose: to make the world a safer, more secure and sustainable place. Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. We take delight in knowing that our work makes a meaningful contribution to society, and we are proud that our culture is centered on integrity, collaboration, inclusion and excellence. UL stands at the forefront of technological advancement, and we are continually challenged to find new ways to foster innovation and positive change. Satisfying? Yes. Exciting? Absolutely!
As our global footprint continues to spread across the world, we are looking for aManagement System Auditor- Medical Deviceswho will join the UL Field Engineering Team.
The Auditor will be taveling to our Clients across Europe for up to 75% of their time and will be carrying out audits of the manufacturer’s quality management system. The position is remote and can be based in the United Kingdom, C entral Europe or any metropolitan area near a major international airport.
What you’ll learn & achieve:
As aMS Auditor, you will be responsible for execution and timely completion of auditing projects. The role exercises Auditor Signature Authority responsible for opening, maintenance, completion, and closing of assigned new work Auditing projects.
Key responsibilities:
Support contract review / agenda setting for quality management system audits
Support regular quality system audits, including CE 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 access 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
What makes you a great fit:
The successful Auditor will have the following proven skills and experience:
successful completion of a 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 the area of quality management;
appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents;
knowledge and experience of risk management and related device standards and guidance documents;
knowledge of quality management systems and related standards and guidance documents;
knowledge and experience of the conformity assessment procedures in the listed programs (MDSAP, ISO13485, MDD/MDR, IVDR etc);
Experience in medical devices (active or non-active ie. dental devices, or blood & tissue products) with a focus on processes such as testing, design and development, manufacturing, quality assurance
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 appropriat ely carried out
Outstanding communication skills with both colleagues and Clients
Client-centric, Agile, Collaborative, taking pride and striving for excellence
Sounds like you? Please send us a copy of your CV in English. We are looking forward to meeting you!
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What you’ll experience working at UL:
Mission:For UL, corporate and social responsibility isn’t new. Making the world a safer, more secure and sustainable place has been our business model for the last 125 years and is deeply engrained in everything we do.
People:Ask any UL employee what they love most about working here, and you’ll almost always hear, “the people.” Going beyond what is possible is the standard at UL. We’re able to deliver the best because we employ the best.
Interesting work:Every day is different for us here as we eagerly anticipate the next innovation that our customers’ create. We’re inspired to take on the challenge that will transform how people live, work and play. And as a global company, in many roles, you will get international experience working with colleagues around the world.
Grow & achieve:We learn, work and grow together with targeted development, reward and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles.
Working at UL is an exciting journey that twists and turns daily. We thrive in the twists and revel in the turns. This is our every day. This is our normal.
Learn More:
Curious? To learn more about us and the work we do, visit UL.com
Connect With Us! (https://nonusenglish-ul.icims.com/jobs/33273/management-system-auditor–medical-devices/job?mode=apply&apply=yes&in_iframe=1&hashed=-336114764)
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LocationGB-London | DE | FR-Paris | DK-Ballerup | NL-Amsterdam | BE-Belgium | PL-Warsaw
Job ID 2023-33273
Job Category Engineering
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