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Senior Consultant Medical Devices Quality

United States, Minnesota, MinneapolisMedical Devices

Job description

What you'll do
Currently, Qserve has an exciting opportunity to join our team as a Senior Consultant Quality in the medical device domain. As a senior consultant, you will be a part of an interdisciplinary group of consultants. Leveraging your experience in Quality management systems for medical devices, MDSAP and auditing, you will be responsible for helping Qserve clients facilitate their business goals by (hands-on) help. You will perform internal or supplier audits, conduct MDSAP mock audits or support your client during Notified body audits or FDA inspections. You may lead or participate in QMS improvement projects, assuring regulatory compliance for a wide range of medical devices, many of which are novel applications.


Job requirements

What you’ll bring to the team

The candidate we are looking for is a highly motivated and passionate Senior Quality expert for Medical Devices. You have auditor qualifications and perform internal or supplier audits on a regular basis. Knowledge of the requisite regulatory requirements in the EU and the US is required. We are looking for someone who is pragmatic, enjoying a mix of activities, products, business processes, quality assurance and regulatory affairs.


Your profile:

  • You have a technical or scientific degree (BSc, MSc or PhD) preferably in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology or similar;
  • At least 7 years of working experience in the medical devices industry in Europe or US through positions in industry, consultancy, Notified Body or FDA, in either quality or regulatory (e.g. Manager Quality Assurance or Manager Quality and Regulatory);
  • Auditor qualifications (ISO13485, MDSAP, 21CFR820);
  • Communicative and service-oriented;
  • Fluent in English;
  • Working permit and driver's license.


Interested?

Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!


* This function will be executed remotely most of the time. We are open to candidates from all over the US.

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How we hire

Everything you need to know about your application process at Qserve Group

Getting to know you

In the first call, let our recruiter learn about you and your story to check a potential fit for Qserve. This is also a chance for you to ask first questions about the role and company.

Interview

In this meeting, your future manager takes a deeper dive into your experience and what you could bring to the team. Expect questions on how knowledgeable you are in your area of expertise.

Final chat

You made it to the very last stage! Here we have a final call to ask some additional questions. This meeting will be between you, your future manager and a team member.

Mutual interest

Is there a match? Then we will gladly make you an offer consisting of a suitable salary and our employment conditions. Do you accept our offer? Your adventure at Qserve Group will start!