Quality Assurance Engineer

STENTiT is a medical device startup based at the High Tech Campus in Eindhoven Netherlands with the aim is to help 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

Now we are looking for our Quality Assurance Engineer at our Eindhoven headquarters.

This is a unique opportunity for an ambitious multitalented individual who wants to see the inside of a fastmoving startup and shape the development of this firstofakind medical device.

You will get insights into a unique company that has the vision to become one of the worlds leading players in regenerative endovascular implants.

You will be responsible for ensuring the quality compliance of devices according to the applicable laws regulations standards and guidance. You will establish and implement a quality system to support development and manufacturing of an implant within the company (most of the manufacturing process occurs onsite in a newly build cleanroom). The position can be parttime.

Tasks

• Develop and Maintain 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 companys 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 ICHGCP 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 510 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 ICHGCP 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.

Benefits

• 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 firstofakind medical product to safe patient lives.

Sounds interesting We look forward to meeting you. Submit your CV and all relevant working documents online now!