For a dynamic health tech company in Amsterdam, I am looking for a QA Officer. This organisation is on a mission to make their health solution accessible to everyone.
In this role you’ll be responsible for the maintenance and improvement of the QMS and to work out the regulatory strategy. Besides that, you’ll work closely with R&D, Customer Support and Management to ensure compliance.
This organisation sees QA/RA as the differentiator in the company and you’ll get the opportunity to lead the way.
Maintain and optimize the QMS
Develop and execute company’s regulatory strategy working closely with the senior management team
Provide guidance during Internal- and external audits
CAPAs, Risk Management, NCRs
Oversea continuous compliance for medical software (MDD/ MDR)
Master’s degree in Life Sciences, Engineering, Law or other scientific area
At least 2 years’ experience in QA, preferably within Medical Devices. Experience in a software environment is a plus
Familiar with ISO13485, MDD/ MDR, FDA.
Excellent English verbal and written skills
Pro-active, independent, analytical and result-driven
ORGANISATION AND OFFER
This organisation is a high-tech healthcare startup offering a world's first CE-certified tele-health solution. Their mission is to make it accessible to everyone.
Courage, impact, curiosity, quality and honesty are important values to them. And at least of the same significance are our team values: open mindedness & respect.
The organisation offers a competitive salary and benefits.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org