Job Description
We are seeking a Quality Engineer to provide Process and Quality Engineering support on the manufacturing side.
This role involves supporting product development teams to help guarantee high-quality new products.
Key Responsibilities:
* Identifying and managing manufacturing process defects.
* Participates in teams focused on identifying Root Cause Analysis (RCA) and implementing Corrective Action Preventative Actions (CAPA).
* Queries and analyzes data to support process improvements.
* Documents release criteria for products and processes.
* Creates Process Monitoring Systems by identifying critical process steps and implementing strategies to reduce variation.
* Supports New Product Introduction (NPI), processing, monitoring & releasing medical device products.
* Assesses the compliance of systems, operations, and practices with regulations and company documentation.