Job Title:
Location: Inchinnan
Position Objective:
We are recruiting for a Quality Engineer to join our small team onsite in Inchinnan. The role will establish and maintain outstanding Quality Systems that align with ISO13485 and FDA 21CFR Part 820. Assure compliance with both internal and external specifications and standards. Actively lead data collection, trend analysis, investigations, and improvements to processes, products, and systems.
Essential Functions:
1. Collaborate closely with Production, Technical, and Manufacturing Engineering teams to resolve quality-related issues from customer complaints/concerns and internal incidents. Facilitate investigations and resolution of related quality issues.
2. Partner with technical support and manufacturing to build and modify methods and procedures, ensuring that appropriate processes, products, materials, and manufacturing equipment meet stringent standards.
3. Aim to improve efficiency in procedures and processes without compromising quality. Identify and implement improvement opportunities across the operational facility.
4. Conduct statistical analysis to identify trends, investigate root causes, and lead corrective actions for processes and products.
5. Maintain a detailed knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR).
6.