Company description
An 3D printing company
Function description
You will work as an engineer to support the manufacturing of products in the high tech, space, aerospace and healthcare industries. The job will focus on Personalized Healthcare Solutions within the healthcare industry.
Job requirements
* Understand and document customer needs to ensure product alignment with customer requirements.
* Lead customer complaints, production nonconformities and CAPA investigations to support continuous improvement.
* Lead root cause investigations and search for effective solutions within a multidisciplinary team to resolve production issues.
* Support the Management Review Board to ensure rejected products are properly disposed, risks are mitigated and support production continuity.
* Handle technical customer requests and secure proper introduction into production.
* Participate in a cross-functional team to reduce risks related to the manufacturing process through pFMEA review.
* Contribute to the validation of manufacturing processes.
* Contribute to the continuous improvements of quality processes by identifying and leading improvement projects.
* Support customer audits.
* Provide support to the QC department regarding customer specifications and inspection methods.
* Lead improvement projects for inspection equipment and methods.
* Contribute to compliancy with ISO 13485, AS 9100 and FDA QSR standards.
Employment conditions
* Master’s degree in engineering.
* Excellent communication skills.
* Strong documentation skills with experience with GDP.
* Analytical mindset with a strong motivation to implement improvements.
* Minimum 3 years of work experience, preferably in the healthcare, aerospace or high-tech industry, within the quality department.
* Good organizational skills.
* Ability to work independently while collaborating effectively within a team.
* Works well under time pressure.
* Fluent in English, Dutch knowledge is a plus.