• Lead Auditor

    Location US-IL-Northbrook | US-AR-Rogers | US-AR-Bentonville | US-CA-San Luis Obispo | US-CA-Fremont | US-CA-Brea | US-CA-Agoura Hills | US-CT-Windsor | US-FL-West Palm Beach | US-GA-Atlanta | US-GA-Marietta | ...
    Job ID
    2018-11033
    # of Openings
    1
    Job Category
    Engineering
  • Overview

    Contribute to a Safer, More Secure, and More Sustainable World!

     

    #ThisIsOurNormal

     

    At UL, we know why we come to work. Thousands of us around the world wake up every day with one common purpose – to make the world a safer, more secure, and more sustainable place to live. We clear the way for our customers to introduce the latest products, technological advances, and systems in an increasingly complex world so they can provide peace of mind to the market. Our integrity is woven throughout our company and shapes the way we approach and deliver our solutions. We are proud that the work we do every day has a meaningful contribution to society. We continue to build upon our legacy of trusted expertise and partnership to keep our communities safe and secure as we march forward into the future. This helps us to sleep better at night, and we are confident that the millions of people we touch rest easier too.

    Responsibilities

    We are currently seeking a Lead Auditor to join our growing team! This is a remote opportunity that can be located anywhere throughout North America! 

     

    In this position, you will be responsible for auditing our customers within Medical Device manufacturers, ensuring they remain compliant with standards. A successful Lead Auditor will have a background in auditing and medical devices, possess a technical acumen, have exceptional customer service skills (verbal and written), be detail-oriented, and thrive in a fast paced environment.


    If this sounds like an exciting opportunity, we want to hear from you!

     

    Additionally, you will be responsible for:

     

    • Identifing and managing priorities as demonstrated by the ability to establish, track, and meet schedules for multiple projects while maintaining project quality.
    • Having strong customer focus and flexibility.
    • Demonstrating a confident, calm and decisive personality.
    • Performing audits at the customer site lasting anywhere from 2 to 10 business days.
    • Performing contract review/project planning for technical file/design dossier evaluations and quality management system audits.
    • Assessing technical file/design dossier and quality management systems against European Directives, essential requirements and latest common technical specifications.
    • Supporting regular quality system and technical audits, including unannounced audits.
    • Subject to training and qualification milestones, perform key CE certification responsibilities to support safe products to market.
    • Performing key development and support of UL’s Medical Device processes for future CE Regulations.
    • Participating in the development and delivery of training materials to UL assessors.
    • Participating in the development of UL requirements and assessment methods.
    • Integrating continuous improvement concepts into all aspects of the job.
    • Providing guidance and support to customers as required and participating in client training and customer forums.
    • Overseas travel may be required.

    Qualifications

    • Electrical Engineering degree
    • Registered (IRCA and/or RABQSA) Quality and/or Environmental and/or Occupational Health & Safety Lead Auditor is preferred.
    • Have satisfactorily completed an RABQSA or IRCA approved training course in Quality and/or Environmental and/or Occupational Health & Safety System operation and auditing.
    • Have competent working knowledge of ISO 13485 and relevant medical device directive (MDD) and invitro diagnostic devices directive (IVDD).
    • Be academically qualified in a recognized scientific/technological discipline.
    • Proven ability in the practical application of quality assurance and/or medical or in vitro dialogistic devices.
    • Ability to travel, including a valid passport and driver’s license

    *Internal title for this position is Staff Engineer 

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