Site Quality Control Manager

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 is a leading specialist provider of minimally invasive cardiac devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a global leading specialist provider in cardiac devices, addressing congenital heart defects, stroke prevention, and heart failure. Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with more than 190,000 products sold. The company markets and sells its products in over 80 countries and has around 330 employees.

Registered in Switzerland, Occlutech employs around 300 people and has manufacturing and R&D facilities in Germany and Türkiye, a global finance and distribution hub located in Helsingborg, Sweden, as well as clinical operations in Minneapolis, U.S

Site Quality Control Manager

Working Days: Monday–Friday (07:30-16:30)

Reports to : Global Director Quality Control

Your work will focus on

• Manages QC, Non-Conforming Product and Calibration/Measurement Devices processes in compliance with QMS, FDA and ISO 13485 requirements.
• Plans and manages QC activities, identifies potential issues and implements corrective actions.
• Ensures compliance with relevant SOPs, safety rules, work processes and protocols.
• Supports process development, documentation and continuous improvement activities.
• Manages, instructs and trains QC staff as needed.
• Supports risk management and CAPA activities, including identification, analysis and follow-up of quality-related issues.
• Plans and optimizes incoming, outgoing and in-process quality controls.
• Performs failure tracking and analysis and supports manufacturing process optimization.
• Monitors and evaluates quality indicators.
• Cooperates with other technical departments on quality-related matters and projects.
• Represents the department in relevant internal and external meetings.

We are looking for a candidate, who

• Diploma, certificate or other evidence of formal qualification, awarded on completion of an university degree or of a course of study recognized as equivalent by the Member State concerned, in medicine, pharmacy, engineering or another relevant scientific discipline, and at least four years of professional experience in quality management systems relating to medical devices and Quality control activities.
• Previous experience on managing a team in a similar industry.
• Practical knowledge and training in GMP, ISO 13485, GAMP5.
• Preferred practical knowledge on ISO 11135, ISO 14644.
• Strong written, oral, and interpersonal skills.
• Proficiency in English.
• Knowledge on quality analysis techniques and problem-solving methods.
• Practical knowledge on Change Management Processes.
• Practical knowledge on Process, system and equipment validations.
• Practical knowledge on Calibration and its management.
• Practical knowledge on cleanroom

If you are a motivated and experienced Site Quality Control Manager looking to make a difference, we would love to hear from you.