Compliance Officer Supervisor

3 days ago


Fatih, Istanbul, Turkey Fresenius Medical Care Full time

About Fresenius Medical Care

We are a leading global provider of products and services for individuals with renal failures, and we're seeking a highly skilled Quality Assurance Supervisor to join our team.

Key Responsibilities

  • Drive Quality & Regulatory compliance across the organization, ensuring alignment with business needs & objectives.
  • Manage Field Action activities, collaborating with HQ and third-party intermediates to achieve timely closure.
  • Ensure timely reporting of PMS activities, including customer complaints and field actions.
  • Solve customer and supplier inquiries related to product quality assurance, ensuring global procedure compliance.
  • Maintain an effective Quality Management System, supporting ISO 13485 and ISO 9001 matrix certificate continuity.
  • Conduct QMS and authority audits, overseeing CAPA management and timely actions.
  • Foster collaboration with external auditors and regulatory agencies during audits and follow-ups.
  • Develop and implement QA audit plans in various facilities.
  • Provide quality training to employees and manage documentation systems.
  • Oversee HSE-related activities within the company.
  • Support the department in meeting Quality KPIs and taking necessary actions.
  • Lead multidisciplinary and regional/global projects to achieve quality goals or compliance, aligned with business needs.

Requirements

  • University degree, preferably in a scientific discipline.
  • Min. 4-5 years of experience in Quality System Management in medical device and/or pharmaceutical industries.
  • Auditing experience is essential, with preferred auditor certifications.
  • Knowledge of healthcare, medicine, and/or biomedical sectors, along with MDD/MDR regulations.
  • Fluent English language skills.
  • Proficiency in MS Office applications.
  • Strong analytical and problem-solving abilities.
  • Effective communication and presentation skills.
  • Excellent organizational and time-management skills.
  • Ability to collaborate, multitask, and prioritize tasks efficiently.


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