Research & development - Wageningen | Just now
Leading and Ensuring Quality Across imec’s R&D Programs While Supporting Multidisciplinary Teams and Cross-Site Initiatives
What you will do
As a Quality Engineer, you will enhance and manage our quality management system by coaching and training project teams on implementing procedures, while actively supporting quality assurance activities within our projects. This role can also be combined with another discipline, such as system engineering or project management - to broaden your scope and impact.
You will play a key role across imec’s offices in the Netherlands, located in Eindhoven (Holst Centre) and Wageningen/Nijmegen (OnePlanet Research Center), contributing to programs in Health, Automotive, and Industry & Consumer application domains. We’re seeking a strong personality who can collaborate with our regulatory engineer to guide device design and development from the early concept phase, support multidisciplinary teams of researchers, engineers and scientists, and take a leading role in shaping the quality direction for imec The Netherlands alongside the quality team at imec headquarters in Leuven Belgium.

Other tasks include:

• Define, maintain, and roll out internal procedures for medical device quality assurance and use in clinical studies (in line with ISO 13485 and MDR). Reuse the best quality practices for our activities.
• Be part of our R&D teams (customer projects) and implement quality control activities.
• Create training material, templates and examples and train the team members.
• Define and align the strategy for migrating our medical device–oriented quality system to other application domains in collaboration with the Quality team in Leuven.
• Take the lead in managing, documenting, and reporting the quality aspects for imec The Netherlands and its projects to management.
• Act as the quality ambassador in the Netherlands, serving as the primary liaison between local teams and the global Quality team.
• Contribute to imec The Netherlands internal committees advising about security, ethical, and medical items.
• Participate in Risk Management process activities according to ISO 14971.
• Strengthen our supplier and customer management processes.
• Additional tasks, depending on the background of the candidate, may include engineering and project management 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.
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 offers a wide range of training possibilities. For international candidates, we provide support in the relocation process.
By joining imec, 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 a technical engineering field with 5+ yrs of experience.
• Proven experience in Quality Assurance related to the development of medical devices and their use in clinical studies is a must.
• Experience in R&D environment is preferred.
• You have a strong personality, and you can drive quality initiatives while remaining collaborative, listening actively, and working effectively within teams.
• Ability to manage quality expectations of stakeholders; e.g. suppliers, customers and imec teams.
• Experience with quality-oriented product development processes and improvement approaches like Six Sigma, is a big plus.
• Interest in multiple application domains such as medical, automotive and industrial, is preferred.
• Ability to deal with ambiguity, seeing 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.
• Excellent communication skills in English (written and spoken). Dutch is a plus.

Interested
Are you interested in this position, and do you want to learn more about it? Then you can connect to Mayuri Nalawade, Talent Acquisition Specialist. You can reach Mayuri at Mayuri.Nalawade.ext@imec.nl. If you wish to apply, then please submit your full resume and include a motivational letter.

• Define, maintain, and roll out internal procedures for medical device quality assurance and use in clinical studies (in line with ISO 13485 and MDR). Reuse the best quality practices for our activities.
• Be part of our R&D teams (customer projects) and implement quality control activities.
• Create training material, templates and examples and train the team members.
• Define and align the strategy for migrating our medical device–oriented quality system to other application domains in collaboration with the Quality team in Leuven.
• Take the lead in managing, documenting, and reporting the quality aspects for imec The Netherlands and its projects to management.
• Act as the quality ambassador in the Netherlands, serving as the primary liaison between local teams and the global Quality team.
• Contribute to imec The Netherlands internal committees advising about security, ethical, and medical items.
• Participate in Risk Management process activities according to ISO 14971.
• Strengthen our supplier and customer management processes.
• Additional tasks, depending on the background of the candidate, may include engineering and project management tasks