Supplier Quality Expert - Medical Devices (ISO 13485)

Fresenius Medical Care; Muratpaşa; On-site; TRY 180,000 - 260,000; Full time

Job summary

Fresenius Medical Care in Antalya, Turkey, seeks a Supplier Quality professional for the Bloodlines division to lead supplier quality activities and QA systems across sites. The role requires 2–4 years of relevant experience and ISO 13485 knowledge.

English proficiency and willingness to relocate to Antalya are essential. You will contribute to maintaining high-quality materials and processes in a global healthcare leader.

Qualifications

• Bachelor's degree in engineering, quality management, life sciences, or related field.
• 2–4 years of experience in supplier quality, QA, or related function.
• Knowledge of ISO 13485 and medical device quality requirements.
• Experience with supplier audits, qualification, and quality systems.
• Understanding of CAPA, Change Control, risk management, and validation.
• Strong analytical and problem-solving skills.
• Effective communication and stakeholder management abilities.
• Proficiency in English (written and spoken).
• Living in Antalya or willing to relocate.

Responsibilities

• Manage Supplier Quality activities within the Bloodlines division.
• Implement Supplier Quality Assurance systems across assigned regions and manufacturing plants in alignment with global policies and SOPs.
• Deploy Supplier Quality SOPs and conduct related training activities at manufacturing sites.
• Lead supplier qualification, selection, evaluation, and continuous development processes.
• Plan and perform supplier audits (on-site and remote) in accordance with ISO 13485 and applicable regulatory requirements.
• Ensure raw material and product quality throughout the supply chain.
• Investigate, analyze, and manage supplier-related deviations, customer complaints, and CAPA processes.
• Assess and approve supplier-related changes through Change Control procedures.
• Support supplier and manufacturing site transfer projects.
• Collaborate with suppliers on process validation, risk management, and change management activities.
• Monitor supplier performance metrics and drive continuous improvement initiatives.
• Prepare and present quality reports, trend analyses, and process improvement recommendations.

Skills

Supplier Quality

Quality Assurance

Quality Engineering

CAPA

Change Control

Risk Management

Data Analysis

Communication

English

Stakeholder Management

Regulatory Awareness

Education

Bachelor's degree (Engineering/QA/Life Sciences)

Job description

Fresenius Medical Care in Antalya, Turkey, seeks a Supplier Quality professional for the Bloodlines division to lead supplier quality activities and QA systems across sites. The role requires 2–4 years of relevant experience and ISO 13485 knowledge.

English proficiency and willingness to relocate to Antalya are essential. You will contribute to maintaining high-quality materials and processes in a global healthcare leader.