Quality Assurance Specialist
6 dagen geleden
We are a medical device startup based at the High Tech Campus in Eindhoven, Netherlands, with a mission to help people suffering from cardiovascular issues. Our goal is to develop a novel class of regenerative endovascular implants for the treatment of cardiovascular diseases, with the ultimate aim of restoring the affected blood vessel from the inside out to provide a lifelong solution.
Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at our Eindhoven headquarters. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality compliance of our medical devices according to applicable laws, regulations, standards, and guidance.
Key Responsibilities- Develop and maintain a harmonized Quality Management System (QMS) in compliance with ISO 13485 requirements.
- Stay up-to-date with developments in quality control and advise on quality actions.
- Guarantee Risk Management tasks are performed according to company expectations.
- Ensure that internal and external audits are conducted in a timely manner.
- Support suppliers to ensure their products and services meet quality standards and specifications.
- Responsible for creating and finalizing the CAPA system and setting the CAPA policy.
- Manage the Design History File (DHF) and Device Master Record (DMR) in accordance with US and European regulatory requirements.
- Collaborate with relevant departments to develop manufacturing documentation, including work instructions and production records.
- Close collaboration with the Regulatory Department to ensure compliance with ISO14155, ICH-GCP, Medical Device Regulation, and other applicable national or international requirements.
- Support QC processes.
- Conduct employee training.
- Master or PhD in Engineering or a scientific degree is mandatory.
- At least 5-10 years of experience in Quality Assurance in a MedTech company, preferably with own manufacturing facilities, is mandatory.
- Experience in developing and maintaining a harmonized Quality System in compliance with ISO 13485 is mandatory.
- Familiarity with statistical methods, risk management, root cause analysis, and process validation is an advantage.
- Experience in quality audits and employee training is an advantage.
- Experience working in clean room environments is an advantage.
- Knowledge of regulatory requirements such as ISO14155, ICH-GCP, Medical Device Regulation, technical documentation requirements, and other national and international requirements is an advantage.
- Knowledge of regulatory submissions and requirements is an advantage.
- Ability to work in a dynamic and multitasking environment.
- Data processing and analysis skills.
- Excellent communication skills in Dutch and English.
- Great opportunities for personal and professional growth in a committed, innovative, and dynamic team.
- Challenging and varied tasks in an innovative environment with real impact.
- Experience entrepreneurship firsthand.
- Rare opportunity to actively shape the development of a first-of-a-kind medical product to save patient lives.
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