Purpose

The Quality Engineer provides daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety). Is responsible for assuring all requirements are met for the Product Development Process (PDP), Risk Management, Design Controls, Usability Testing, Production Controls, post market product surveillance. Works independently on highly specialized projects. Exercises judgment in determining technical objectives of assignments. Selects methods and techniques to fulfill quality requirements. May develop or contribute to departmental technical policies and procedures.

Key Responsibilities
- Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
- Understanding of product quality plans,



documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs.
- Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
- Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development.
- Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
- Checks and provides support in the execution and investigation of CAPAs, NCs, Failure Mode Investigations, Complaints, etc.
- Evaluates new equipment and processes and participates in the transfer of new produc

📌 Quality Assurance Engineer (Roma)
🏢 BVI Medical
📍 Roma