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Auditor Medical Devices (home-office based, location flexibl

at UL, LLC in

Job Description

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! Within ourLife & Health Sciences division, we work every day to not only protect life, but also protect hope. We enable people around the world to access the most advanced care to treat themselves and their loved ones. We help our clients understand the specific needs of different patient groups and design and implement products that will work to ensure safety in healthcare. As our global footprint continues to expand, we are looking for a Auditor Medical Devices (home-office based, location flexible within Europe)

What you’ll learn & achieve:

In this role you will performMedical Management System Auditsrelated to ISO 13485, MDSAP, MDD/MDR:

+ Perform quality management system audits with particular focus on the EU customers, subject to training and qualification milestones

+ Support unannounced audits.

+ Support Competent Authority activities on as needed basis e.g. witnessed audits of UL.

+ Provide support to customers inquiries, meetings, and other customer events.

+ Participate in regular training on ISO standards, applicable regulations, and associated guidance.

+ Frequent domestic travel is required, with some international travel.

+ Perform other duties as required.

What makes you a great fit:

+ Bachelor or Master’s Degree in science discipline e.g. Physics, Electronics, Engineering

+ Hands-on technical experience in active medical devices, non-active dental devices, or In-Vitro Diagnostic devices preferred.

+ Useful experience may include testing, design and development, manufacturing, quality assurance, or monitoring experience.

+ Product experience could include x-ray, imaging, patient monitoring devices, etc.

+ Non-active device experience may include ligatures, braces, burrs, surgical instruments, etc.

+ Reagents and reagent products, calibrators and control materials for:

+ Clinical Chemistry, Immunochemistry (Immunology), Haematology/ Haemostasis/ Immunohematology, Microbiology, Infectious Immunology, Histology/ Cytology, Genetic or Batch Testing.

+ Familiar working with quality management systems certified to ISO13485.

+ Auditing experience, ideally with another registration body or have completed an IRCA registered course or conducting internal audits.

+ Must possess business fluent command of written and spoken English

+ Very good written and verbal communications skills as well as strong client-interfacing skills

+ A commitment to be a lifelong learner

+ Please note:Frequent European and international travel is required (up to 80% max.)- you can be located anywhere within Europe since you will be working remotely, but it is mandatory that you livenear an international airport

What you’ll experience working at UL:

+ Mission: At UL, we know why we come to work. Shape the way we approach and deliver our solutions to have a meaningful contribution to society.

+ People:Be part of our global team and do your best work! Teamwork, open-feedback and our diversity are our drivers to reach our common mission.

+ Interesting work:The work that goes on inside UL is fuelling the future. It challenges you to try fresh approaches, work autonomously, drive change and gain in-depth experience in your field.

+ Grow & achieve:Growth and development are part of our DNA. Grow & achieve with targeted development, reward and recognition programs as well as your very own UL University.

+ This is our normal:Competitive remuneration, annual bonus, flexible work options, 2 volunteer days per year

Learn More:

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. Curious? To learn more about us and the work we do, visitUL.comand ourHealthcare & Life Sciences division website (https://www.ul.com/industries/healthcare-and-life-sciences) UL is an Equal Opportunity Employer and we welcome applications from all sections of the community. Our Talent Acquisition team can provide further information and support reasonable adjustments that a person may require during the interview process. You can read more about our commitment to supporting a diverse and inclusive environment here:https://www.ul.com/about/diversityor contact our Talent Acquisition team regarding specific needs here: recruitmenteurope@ul.com

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LocationDE-HE-Neu-Isenburg | DE | ES-Barcelona | IT-Carugate | FR-Lyon

Job ID 2021-23020

  1. of Openings 1

Job Category Engineering

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Job Posting: JC184291509

Posted On: May 23, 2021

Updated On: Aug 19, 2021