Quality Assurance Supervisor

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).