Quality Engineer
Imec
- Wageningen, Gelderland
- Vast
- Voltijds
- 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.
- 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.