Fresenius Medical Care

Quality Assurance Supervisor

Istanbul

November 7, 2024

Quality Assurance Supervisor

Job Description
  • Supporting Q&R team in driving Quality & Regulatory compliance while aligning overall organization to meet business needs & objectives,
  • Follow up initiated Field Action activities with HQ and third party intermediates, support the company for timely closure,
  • Ensure timely authority reporting for PMS activities (customer complaints, field actions),
  • For customer product complaints, resolve customer or supplier inquiries related with product quality assurance related matters and support the company about being compliance to global procedure,
  • Ensure an effective Quality Management System is in place, support continuity of ISO 13485 and ISO 9001 matrix certificates,
  • Conduct QMS and authority audits, manage CAPAs and ensure timely actions taken, as well as other relevant core quality processes,
  • Interface with external Quality Auditors and Regulatory Agencies during audits and their follow-up,
  • Planning and performing QA audits in our warehouses, water treatment system production plant and other branches,
  • Performing Quality trainings to employees and manage documentation system,
  • Follow up of HSE related activities within the company,
  • Support the department to meet Quality KPIs, and take necessary actions when needed,
  • Coordinate – multidisciplinary and regional or global – projects to maintain or obtain quality goals or compliance, in accordance with the business needs.

Qualifications

  • University degree, scientific discipline is preferred,
  • Position will be located in our HQ, in Istanbul and will be able to travel in Turkey & abroad,
  • Min. 4-5 years of experience in Quality System Management in medical device and/or pharmaceutical industry (namely, ISO 9001, ISO 13485, CE Marking, MDR, ISO 14001, OHSAS 18001),
  • Auditing experience is a must, preferably having auditor certificates for the above mentioned management systems,
  • Experience in health care, medicine, and/or biomedical sectors; knowledge on MDD/MDR regulations,
  • Preferably C Class Occupational Health and Safety Certificate,
  • Fluent in English (written and spoken),
  • Proficient in MS Office applications,
  • Analytical thinking and problem-solving skills,
  • Strong communication and presentation skills,
  • Strong planning, follow up, reporting and organization skills to achieve accurate and timely results,
  • Collaborative team player, Multitasking,
  • Able to prioritize and triage issues for efficient resolution,
  • No restrictions on ability to travel,
  • No military service obligation (for male candidates).
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