Senior Quality Assurance Specialist

EVMANN YÖNETİM HİZMETLERİ VE DANIŞMANLIK ANONİM ŞİRKETİ

We are looking for a Senior Quality Assurance Specialist to joinStreliza Corp., an EVMANN Holding company.

The position will be responsible for supporting the effective management and continuous improvement of the Quality Management System (QMS), as well as quality and regulatory compliance processes. We are looking for a highly motivated professional with strong expertise in quality assurance and regulated industries to join our team.

Required Qualifications

• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology, Pharmacy, Biomedical Engineering, or a related field.
• 5+ years of experience in Quality Assurance, preferably within themedical device, pharmaceutical, or other regulated industries, with priorteam management experience preferred.
• Strong knowledge of ISO 13485, ISO 14971, ISO 24971, EU MDR 2017/745, and MDSAP requirements.
• Fluent in English, both written and spoken.
• Willingness and ability to travel to the U.S. as required; a valid U.S. visa is preferred.
• Strong leadership, coordination, and team management skills.
• Excellent attention to detail and analytical thinking.
• Strong regulatory and quality compliance mindset, with a continuous improvement approach.
• Strong project and time management skills.
• Ability to work effectively in cross-functional teams and collaborate with different departments.

Responsibilities

• Manage and maintain all Quality Management System (QMS) processes and documentation; monitor QMS effectiveness through performance indicators and data analysis.
• Ensure compliance with ISO 13485, ISO 14971, ISO 24971, EU MDR 2017/745, MDSAP, and other applicable legal and regulatory requirements.
• Ensure the development, revision, approval, and implementation of quality procedures and records; leadcontinuous improvement activities across quality processes.
• Serve as the Management Representative in accordance with ISO 13485 requirements.
• Fulfill PRRC responsibilities in accordance with Article 15 of MDR 2017/745; oversee technical documentation, product conformity, PMS, vigilance, and regulatory processes.
• Coordinate and monitor CAPA, nonconformity, deviation, change control, root cause analysis, and risk management processes, ensuring their timely completion and effectiveness.
• Plan and coordinate internal and external audits; manage audits conducted by Notified Bodies and Competent Authorities and follow up on corrective actions.
• Ensure effective management of documents and records, supplier quality, quality training, and related compliance processes.
• Prepare quality data and KPI reports for Management Review; analyze quality trends and recommend continuous improvement actions.
• Manage product release activities as theLegal Manufacturer and verify product compliance with technical documentation, quality standards, and applicable regulatory requirements.
• Coordinate the assessment of quality risks and risk mitigation activities throughout the product lifecycle in collaboration with relevant departments.
• Report quality and regulatory matters to management, escalate issues when necessary, and initiate appropriatecorrective and preventive actions