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Rigorously manages the CAPA process, investigates nonconformances, drives root cause analysis, implements corrective/preventive actions, and oversees Quality Notifications (QNs) and Non-Conformances (NCs).
Leads validation activities for process controls, supports design changes, PFMEA assessments, and ensures robust manufacturing process development and successful New Product Introductions (NPI).
Collaborates cross-functionally with R&D, manufacturing, and regulatory teams to drive strategic quality improvements and elevate supplier performance.
Oversees factory-level quality systems and product transfer validations, acting as the QMS process owner to ensure compliance with internal and external quality standards.
Manages and develops team talent, leads key quality engineering tasks, ensures effective risk management, and implements strategic initiatives aligned with organizational goals.
Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such asQuality Engineering, Safety Engineering, Process Engineering or equivalent.
Advanced English level.
This role is an onsite role. / Admin Shift
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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