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About Stentit BV
Stentit BV is a medical device startup based at the High Tech Campus in Eindhoven, Netherlands, with the aim of helping people suffering from cardiovascular issues. We develop a novel class of regenerative endovascular implants for the treatment of cardiovascular diseases. Our ultimate goal is to restore the affected blood vessel from the inside out to provide a lifelong solution.
Job Description
We are looking for a Quality Assurance Specialist at our Eindhoven headquarters. This is a unique opportunity for an ambitious, multi-talented individual who wants to see the inside of a fast-moving startup and shape the development of this first-of-a-kind medical device.
Responsibilities
- Develop and maintain a harmonized Quality Management System (QMS) in compliance with ISO 13485, requirements
- Keep up to date with regard to developments in the sphere of quality control and advise about quality actions
- Guarantee Risk Management tasks are performed according to company's expectation
- Ensure that the process of internal and external audits are in place on a timely manner
- Support suppliers to ensure that their products and services meet quality standards and specifications
- Responsible for creating and finalizing the CAPA system and setting the CAPA policy
- Management of Design History File (DHF) and Device Master Record (DMR) in accordance with US and European regulatory requirements
- Collaborate with relevant departments within the company (primarily R&D and engineering) to develop manufacturing documentation, including work instructions and production records
- Close collaboration with the Regulatory Department to ensure compliance to ISO14155, ICH-GCP, Medical Device Regulation, and other applicable national or international requirements
- Support QC processes
- Conduct employee training
Requirements
- Master or PhD in Engineering or scientific degree - mandatory
- At least 5-10 years of experience in Quality Assurance in a MedTech company, preferably a MedTech company with own manufacturing facilities - mandatory
- Experience in develop and maintain harmonized Quality System in compliance with ISO 13485 – Mandatory
- Familiarity with statistical methods, risk management, root cause analysis, and process validation - an advantage
- Experience in quality audits and employee training - an advantage
- Experience working in clean room environments - an advantage
- Knowledge on regulatory requirements such as ISO14155, ICH-GCP, Medical Device Regulation, technical documentation requirements, and other national and international requirements. – an advantage
- Knowledge of regulatory submissions and requirements - an advantage
- Ability to work in a dynamic and multitasking environment
- Data processing and analysis skills
- Excellent communication skills in Dutch and English
What We Offer
- 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 first hand
- Rare opportunity to actively shape the development of a first-of-a-kind medical product to safe patient lives
