OC Engineer

Occlutech; Bakırköy; On-site; TRY 180,000 - 240,000; Full time

Job summary

Occlutech, a leading medical device company, seeks a Quality Control Engineer to strengthen QMS compliance across our Istanbul site. You will manage QC records, support NCP metrics, and assist change control while ensuring product quality and regulatory alignment.

Requirements include a Bachelor’s degree in engineering, at least four years in QMS or regulatory affairs within the medical device sector, ISO 13485 knowledge, and strong English communication. Proficiency with MS Office is essential.

Qualifications

• Requires ISO 13485 knowledge and 4+ years in Quality Management Systems (QMS) or regulatory affairs within the medical device industry.
• Bachelor’s degree in engineering or related field.
• Strong English communication skills (written and verbal).
• Proficiency with MS Office and Windows-based systems.

Responsibilities

• Organizes and manages Quality Control records.
• Prepare and report metrics for NCP processes at QMS reviews.
• Support change management activities.
• Prepare/analyze quality indicators for the Istanbul site.
• Perform other duties as assigned by Quality Management.

Skills

QMS experience

Regulatory affairs

ISO 13485 knowledge

Teamwork

Communication

English proficiency

Windows/MS Office

Education

Bachelor’s degree in engineering

Tools

Calibration tools

MS Office

Windows OS

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.

QC Department Department

Quality Control Engineer with experience in the medical device industry, contributing to the effective implementation and maintenance of Quality Management System (QMS) processes and compliance with applicable quality requirements.

Responsible for managing Quality Control records, preparing and reporting NCP process metrics for QMS reviews, supporting change management activities, and monitoring and analyzing quality indicators.

The role also includes involvement in product release processes and calibration activities.

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

Reports to : Site Quality Control Manager

Your work will focus on

• Organizes and manages the Quality Control Records.
• Prepare and report metrics for NCP processes at QMS reviews;
• Support change management activities.
• Prepare / analyze quality indicators for the Istanbul site
• Perform other duties as assigned by Quality Management
• Is flexible and open to provide assistance in non-specific daily tasks when and wherever needed

We are looking for a candidate, who

• Bachelor’s degree in engineering or a related scientific discipline,
• Minimum of four years of professional experience in Quality Management Systems (QMS) or regulatory affairs within the medical device industry.
• Knowledge of quality management standards and regulatory requirements, particularly ISO 13485.
• Familiarity with quality tools and methodologies including calibration process.
• Strong teamwork, communication, problem-solving, and interpersonal skills, with a proactive and confident approach.
• Strong written and verbal communication skills in English.
• Proficient in Microsoft Office applications and Windows-based systems.

If you are a motivated and experienced QC Engineer looking to make a difference, we would love to hear from you.