/Quality Engineer – Medical Devices

Quality Engineer – Medical Devices

Research & development - Wageningen | More than two weeks ago

Quality Engineer 

Ensure quality within a dynamic R&D environment.

What you will do

We need you as a Quality Engineer to participate in setting up and managing a quality management system, including coaching, and supporting project teams to work with the procedures. Next to that you also work within our teams to support quality assurance activities, data protection/privacy and medical or environmental device regulations. A combination with another role to broaden the activities is also a possibility. For instance, in combination with system testing or supplier management.

As a Quality Engineer you will have an important role in our activities in environmental sensing and in preparation for human studies like for the ‘ingestible sensor project’. We are looking for a candidate that can team up with our regulatory engineer to support multidisciplinary project teams of biomedical researchers, electronic engineers, biochemical engineers, and data scientists.

Other tasks include:

  • Define, maintain, and roll out internal procedures for medical device development and use in clinical studies (in line with ISO 13485, IEC 62304 and MDR).
  • Give guidance and support to the team with respect to privacy and processing of personal data.
  • Work with the Data Protection Officer (DPO) of imec to ensure that OnePlanet Research Center complies with the GDPR and internal data protection and health care compliance regulations.
  • Build up the knowledge of the interplay between the Clinical Trials Regulation and the General Data Protection Regulation (GDPR).
  • Take the lead in managing and reporting the quality for OnePlanet and its projects to management.
  • Additional tasks, depending on the background of the candidate, may include test set up definition, engineering, or research tasks.

What we do for you

We offer a challenging and international environment at the forefront of technology, in an international network of renowned industrial customers. This is your opportunity to bring new technologies to the market that will have an impact on tomorrow’s society. 

OnePlanet Research Center is a multidisciplinary collaboration agreement between Wageningen University & Research (WUR), Radboud University, Radboudumc and imec. Imec The Netherlands, as an employer of choice, offers you an attractive compensation and benefits package including a 100% employer paid pension plan and flexible working hours. Furthermore, imec-NL offers a wide range of training possibilities. 
 
At the same time OnePlanet is a new collaboration of 3 renowned and globally respected research institutes/universities. By joining the OnePlanet team, you will be part of a team of world changers; disruptive innovators and practical thinkers. Here, your ideas will have an impact on our future lives. 

Who you are

  • Bachelor's or Master's degree in the technical engineering or biomedical field.
  • Work experience in Quality Assurance in relation to the development of preferably medical (research) devices and use in clinical studies is a must. 
  • Experience with quality-oriented product development processes and improvement approaches like Six Sigma is a big plus. 
  • Be able to manage quality expectations for stakeholders like suppliers, customers and our teams. 
  • Interest in both the medical and environmental domain are preferred. 
  • For this position proficiency in the Dutch language is required because of the written language of the regulations, and for clinical studies. We also ask for excellent English language skills because of the international work culture of the organization.
  • Able to deal with ambiguity. You see changes as an opportunity to learn and grow.
  • A quick learner interested in acquiring new skills and competencies.
  • Hands-on attitude, which means taking initiative, thinking pro-actively, having a flexible attitude and solving problems.

Interested

Does this position sound like an interesting next step in your career at imec? Don’t hesitate to submit your application by clicking on ‘APPLY NOW’.

Should you have more questions about the job and the recruitment process, then you can connect with Mayuri Nalawade, Talent Acquisition Specialist. You can reach Mayuri by email at mayuri.nalawade.ext@imec.nl. She will be happy to assist you. If you wish to apply, then please submit your full resume and a cover letter.

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