Job Title: Quality Engineer
We are looking for a skilled Quality Engineer to join our global team.
About the Role:
* Support the introduction of new products and participate in Design transfer meetings.
* Ensure the CTQ cascade from design input to inspection plan.
* Develop measurement systems for ongoing product inspection.
* Plan and execute Test Method validation.
* Conduct Engineering Studies for process characterization.
* Collaborate on process improvement and automation projects.
* Develop control plans and review Production Risk Management documentation.
* Publish reports and presentations for internal and external stakeholders.
Requirements:
* Bachelor's degree in a technical field (Biomedical, Mechanical, Automation engineering).
* At least 3 years of experience in manufacturing (Medical Device, pharmaceutical, automotive preferred) or equivalent combination of education and experience.
* Experience in a regulated environment (ISO13485, CFR 21 part 820, MDR).
* Knowledge of Six Sigma techniques and/or statistical analysis required.
* Proficiency in MS Office, Agile, and Windchill a plus.
* Fluent English communication skills.
* Detailed organization skills, independence, and strong communication at multiple levels.