Senior Quality Control Manager — Medical Devices

Occlutech; Bakırköy; On-site; TRY 600,000 - 900,000; Full time

Job summary

Occlutech, a leading cardiac devices company, seeks a Site Quality Control Manager in Turkey to lead QC, calibration and non-conforming product processes in line with QMS, FDA and ISO 13485. The role requires managing a team and ensuring compliance with SOPs, safety and process controls.

You will drive CAPA, risk management and continuous improvement, collaborate across departments, and report to the Global Director Quality Control. Fluent English and strong communication are essential.

Qualifications

• University degree in medicine, pharmacy, engineering or relevant science, plus 4+ years in quality management for medical devices.
• Experience leading a quality team in medical devices.
• Practical GMP, ISO 13485, and GAMP5 knowledge.
• Nice to have ISO 11135, ISO 14644.
• Strong written and verbal communication; English proficiency.
• Knowledge of quality analysis techniques and problem solving.
• Experience with Change Management, validation of processes/systems/equipment, calibration management, and cleanroom.

Responsibilities

• Manage QC, non-conforming product and calibration devices per QMS, FDA and ISO 13485.
• Plan and manage QC activities, identify issues, implement corrective actions.
• Ensure compliance with SOPs, safety rules and protocols.
• Support process development, documentation and continuous improvement.
• Manage, train and guide QC staff.
• Support CAPA and risk management activities.
• Plan and optimize incoming, outgoing and in-process QC.
• Perform failure tracking and assist process optimization.
• Monitor quality indicators.
• Collaborate with other departments on quality matters.
• Represent QC in internal and external meetings.

Skills

Team leadership

GMP knowledge

Quality analysis

Problem solving

English proficiency

Education

University degree in engineering/medicine/pharmacy

Tools

ISO 13485

GAMP5

Job description

Occlutech, a leading cardiac devices company, seeks a Site Quality Control Manager in Turkey to lead QC, calibration and non-conforming product processes in line with QMS, FDA and ISO 13485. The role requires managing a team and ensuring compliance with SOPs, safety and process controls.

You will drive CAPA, risk management and continuous improvement, collaborate across departments, and report to the Global Director Quality Control. Fluent English and strong communication are essential.