Medical Devices Lead Auditor

3 dni temu

Warszawa, Mazovia, Polska SGS Pełny etat

As a leading company in the testing, inspection, and certification industry, SGS offers a dynamic work environment with a focus on quality and integrity.

Job Description:
  • Develop and deliver auditor training materials for global business scope.
  • Evaluate and approve trainee auditors' L1 audits.
  • Ensure auditor qualifications remain in place and conduct management system audits to meet customer requirements and accreditation standards.
  • Serve as a key expert and mentor to colleagues, playing a crucial role in the qualification of new auditors.

Main Responsibilities:

As a Lead Auditor:

  • Support the development of the SGS medical device auditor network by aiding the qualification of trainee auditors.
  • Act as a key point of contact for SGS medical device offices, mentor junior colleagues, and coordinate the expansion of the IVDR auditor network.
  • Contribute to the continuous improvement of processes and tools used across the SGS network to conduct MDR/IVDR conformity assessment.
  • Maintain own auditor competences.
  • Conduct audits at clients' sites and remotely, following established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
  • Work alone or lead audit teams as appropriate, enhance client satisfaction, and ensure compliance with standards and regulatory requirements.
  • Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
  • Complete specific projects about medical device procedures, processes, systems, and documentation as requested by the Medical Devices Manager.

Qualifications:

  • Fully knowledgeable about EUMDR 2017/745.
  • Previous auditing experience within an MDR notified body is mandatory.
  • A university degree or equivalent qualification in relevant sciences such as Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Physics, Biophysics, Material Science Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology.
  • General Expertise including but not limited to Risk Management (ISO 14971), Usability, Biocompatibility, Clinical Standards and guidance documents relevant to medical devices.
  • Meet the prerequisite per LPMDREG7001 for MDR and/or LPIVDREG7106 for IVDR.
  • Demonstrate 2 years working knowledge on MDN/MDA/MDS codes for MDR.
  • Good English written and verbal skills.
  • Experience of working under own initiative and in planning and prioritising workloads.
  • Willingness to travel Internationally as required.

About Us:

At SGS, we value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential. We are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork.

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