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).
