QA Manager

The organisation

For a revolutionary Startup in Cardiology, we are looking for a Quality Assurance Manager who will lead and oversee the development of the company’s pVAD catheter, and to lead the catheter development team. With an estimated 2 million heart attacks in Europe and the US per year, the organisation strives to increase the survival rates of patients suffering from cardiogenic shock. With their high potential, they recently received a new funding round to develop their product further, and bring this to the market.

The position

This is how you will make the difference
For this mission, they are looking for a QA Manager with experience and intimate knowledge of class III medical devices in interventional cardiology.

Tasks & responsibilities

As the QA Manager, you will work closely with his/her counterparts responsible for device development as well as with other functions. They will provide team and project leadership, and share the responsibility of realising the organisation’s full potential. With your hands-on knowledge and experience you will develop and maintain the quality system for cardiovascular devices. As a Manager of Quality Affairs, you will have excellent communication and coordination skills to lead your team in the further development on this device. You will report directly to the CEO. 

Other activities include but are not limited to:

• Ensure compliance with quality system
• Lead establishment of risk management and risk control processes
• Coordinate comprehensive risk analysis
• Support product development and regulatory functions
• Anticipate risks and challenges; proactively work with relevant functions to ensure development of adequate mitigation plans
• Ensure proper qualification of development and manufacturing vendors

Candidate profile

What you bring
The ideal candidate would be someone with a minimum of 4 years experience in Quality Affairs and a background in a relevant engineering discipline such as biomedical engineering, or equivalent experience. 

Furthermore it would be ideal if you have the following qualifications & characteristics: 

• Intimate understanding of the medical device industry and interventional cardiology device requirements
• Experience in establishing a QMS within a medical device start-up
• Experience with class III cardiovascular devices
• Excellent communication skills in English and preferably one other European language
• Willingness to travel a part of your time

The offer

Next to being part of one of the most promising Startups in the field of cardiology you can expect an annual salary between €80.000 and €110.000 depending on experience.

Interested?

You can apply to this position by using the link below. For more information please contact Tessa Heemskerk, +31 6 12 43 13 59.