Quality Assurance Leader

Randstad Türkiye; Konak; On-site; TRY 2,954,000 - 3,939,000; Full time

Job summary

A global medical device manufacturer is seeking a Quality Assurance Leader in Turkey. You will lead the quality team, manage non-conformities, and ensure compliance with standards. The role requires 7-10 years of experience in quality assurance, especially with ISO13485. Strong analytical skills, teamwork, and proficiency in ERP systems are essential. This position offers an exciting opportunity to contribute to quality processes in a dynamic environment.

Qualifications

• At least 7-10 years of experience in quality assurance.
• Experience with ISO13485 certification applications.
• Strong understanding of quality management systems.

Responsibilities

• Lead the quality team for efficient work distribution.
• Manage non-conformity findings and root cause analyses.
• Ensure compliance with relevant regulations.

Skills

Risk Management

Quality Control

Automation Technologies

Problem-solving

Analytical Thinking

Team Leadership

Communication Skills

Education

Bachelor's/Master's degree in Engineering or related fields

Tools

ERP systems (LOGO or equivalent)

MS Office

Job description

We are looking for a Quality Assurance Leader for a global medical device manufacturer with production facilities in Turkey and headquarters in Austria.

Responsibilities

• Lead the quality team to ensure the most efficient execution of work distribution and expertise.
• Possess knowledge of Risk Management, after-sales processes, and operational quality processes, and manage related activities.
• Have experience in Quality Control and automation-supported monitoring processes.
• Develop and improve quality standards through production and process automation applications.
• Managing non-conformity findings, performing root cause analyses, and developing solutions.
• Contributing to the development of production and processes for existing and new products.
• Review change management activities and integrate them into processes.
• Monitor process quality, track performance criteria, perform analyses and take necessary measures.
• Prepare for internal and external audit processes, play an active role in audits.
• Follow process and equipment validation processes, ensure integration with automation systems.
• İmplemantation and follow up of sterilisation process and sterilisation unit existing within the factory.
• Ensuring compliance with relevant regulations by keeping in line of current legislation and standards.
• Managing supplier quality processes, analysing non-conforming data and prioritising projects.
• Effectively using problem-solving tools to manage corrective and preventive actions with suppliers.
• Regularly presenting quality reports to senior management.

nitelikler

• Bachelor's/Master's degree in Engineering, Science or related fields.
• At least 7-10 years of experience in quality assurance (particularly ISO13485 and other relevant certification applications) and process development. (experience in medical devices, pharmaceuticals and automotive is preferred)
• Knowledge of quality management systems, risk management and validation.
• Proficiency in ERP systems (LOGO or equivalent) and MS Office programmes.
• Good command of English.
• Process-oriented, analytical thinking and problem-solving skills.
• Team player, developed leadership qualities and strong communication skills.
• Proactive, innovative and willing to use automation technologies in quality processes.