Quality Engineer

This is a professional position with responsibilities for elements of the quality program. The Quality Engineer is responsible for ensuring product and process quality throughout the manufacturing cycle, with a strong focus on ISO 13485:2016 compliance, incoming material inspections, equipment validation, and continuous improvement. This role supports internal audits, root cause analysis, and the implementation of corrective and preventive actions. The engineer will work closely with cross-functional teams to maintain high standards of quality and productivity. The quality engineer also serves as a technical reference and subject matter expert for colleagues with less experience.

Responsibilities - (Responsible activities)

• Apply and enforce ISO 13485:2016 quality standards across manufacturing processes, incoming materials, and final inspections.
• Conduct and document First Article Inspections (FAI) and ensure compliance with customer and internal spec...