Full-Time Medical Devices Lead Auditor & Training Specialist

Medical Devices Lead Auditor & Training Specialist opportunity at SGS.

Main Purpose of Role

• Develop and deliver Auditor Training materials.
• Evaluate and approve Trainee Auditors L1 audits.
• Ensure auditor qualifications; support audit planning and conduct.
• Key expert/mentor to colleagues, qualifying new auditors.

Key areas of responsibilities

• As a Lead Auditor
  • Support the development of the SGS medical device auditor network.
  • Witness qualification audits, provide feedback, deliver training and coaching.
  • Key point of contact, mentor for junior colleagues; coordinate IVDR auditor network expansion.
  • Improve processes and tools for MDR/IVDR conformity assessment.
  • Maintain auditor competences, conduct audits at clients’ sites and remotely.
  • Enhance client satisfaction, ensure compliance with standards & regulatory requirements.
  • Complete work within budget and timeframes.
  • Complete specific projects as requested.
• As a Training Specialist/Facilitator
  • Prepare, deliver, assess training and integration aspects.
  • Support Training team with medical device core training courses.
  • Support peer reviews and assessment, maintain knowledge of relevant regulations.
  • Support/deliver external trainings (administrative support).

Essential Skills (Lead Auditor)

• Full knowledge of EUMDR 2017/745
• Previous auditing experience within an MDR notified body
• University degree or equivalent
• Risk Management (ISO 14971), Usability, Biocompatibility, Clinical Standards
• Meet prerequisites per LPMDREG7001 (MDR) / LPIVDREG7106 (IVDR)
• 2 years working knowledge on MDN/MDA/MDS codes for MDR
• Good English written & verbal skills
• Experience in planning and prioritizing workloads
• Willingness to travel internationally

Desirable Skills (Lead Auditor)

• Knowledge of EU IVDR 2017/746
• Appointed Lead auditor by Notified Body under ISO 13485, MDR, IVDR, UKCA
• Working knowledge in IVR/IVS codes for IVDR
• Meeting Prerequisite per LPMDREG7048 section 3 as Level 1 auditor
• Knowledge of other EU languages

Essential Skills (Training Specialist/Facilitator)

• Proven experience in training and assessment
• Experience creating and maintaining training material
• Excellent communication skills
• Bachelor level education (engineering/science/research)
• IT literacy

Why SGS?

• Globally recognized, leader in the Testing, Inspection, and Certification (TIC) industry.
• Flexible schedule and work model.
• SGS University and Campus for continuous learning.
• Multinational environment, collaboration across continents.
• Comprehensive benefits platform.

Open and supportive company culture, diverse workforce.

What is the last date for applying to the job?

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