QA Officer

Location Amsterdam
Discipline: Medical Device
Job type: Permanent
Contact name: Christian Steenkamp

Contact email: c.steenkamp@panda-int.com
Job ref: 12260
Published: about 1 month ago

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.

 

MAIN RESPONSIBILITIES

  • 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)

 

YOUR PROFILE

  • 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 c.steenkamp@panda-int.com