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Lead Auditor

3 months ago

New York, New York, United States X4 Life Sciences Full time

A lead Notified Body client of X4 Life Sciences is looking to add a Lead Auditor for Medical Devices to it's rapidly growing, dynamic team.

Read all the information about this opportunity carefully, then use the application button below to send your CV and application.

About The Role

This role is for medical device certification. The main responsibilities of this role are:

  • Responsibility for achieving his/her own KPI-targets
  • Efficiently and competently implement ISO13485 & MDD & MDR auditing and assessment work for clients based on the CE Directives, International standards, other applicable Regulatory Systems and the client's accredited certification program
  • Ensure work execution with absolute independence and integrity at all times
  • Contribute to the ongoing improvement of operational efficiency and effectiveness by means of the identification and pursuit with regards to audit processes and handling of information within the team and unit, facilitating the rendering of service also to other functions within the organization as required
  • Organize and deliver projects, i.e. assessment, gap analysis, training and customer workshops, etc.
  • Maintain assessor/auditor registration with the client and other relevant authorities to work as a Lead Auditor.
  • Other issues as assigned by the line Manager

What our client offers

  • Flexible work arrangements for better work-life balance
  • Generous Paid Leaves (Sick leaves policy/ Annual leaves policy)
  • Medical benefits - Annual Health Check-up
  • Pension and Insurance Policies – (Pension Insurance, Medical Insurance, Unemployment Insurance, Work related injury insurance, Supplementary Pension)
  • Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
  • Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Housing Fund, Lunch Policy)
  • Profit Share

Interviews are commencing this week, so please apply within if interested.