Medical Device Quality Assurance Specialist

2 tygodni temu

Warszawa, Mazovia, Polska SGS Pełny etat
About the Job

SGS is seeking a seasoned Senior Lead Auditor with expertise in EU In-Vitro Diagnostic Medical Devices Regulation (IVDR) to join our team. As a key player, you will contribute to expanding and developing SGS IVDR certification services across our global network.

Key Responsibilities
  • Develop and lead training programs for new auditors, providing feedback and guidance on their performance.
  • Collaborate with SGS medical device offices as a point of contact, mentor junior colleagues, and facilitate the expansion of the IVDR auditor network.
  • Improve processes and tools used for IVDR conformity assessments, ensuring high standards are maintained.
  • Conduct audits at client sites and remotely, adhering to established procedures and maintaining excellent customer relationships.
  • Lead audit teams as needed, enhancing client satisfaction, and ensuring compliance with regulatory requirements.
Requirements
  • Mandatory experience as an auditor within an IVD or IVDR notified body.
  • A minimum of 4 years 'hands-on' experience in designing, manufacturing, or testing IVDs.
  • At least 2 years of this experience should be in quality assurance/quality management under a structured quality management system.
  • 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.
Preferred Skills
  • Familiarity with EU IVDR 2017/746 and relevant standards/guidance documents.
  • Experience working independently, planning workloads, and traveling internationally as required.
  • Good English written and verbal skills.
Salary and Benefits

The estimated salary range for this role is between $80,000 and $120,000 per year, depending on qualifications and experience. We offer a competitive compensation package, including benefits such as remote working environment, and opportunities for professional growth and development.

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