Senior Quality Engineer - Combination Device

The Senior Quality Engineer will provide Process/Quality Engineering support to manufacturing of combination medical devices, helping to ensure delivery of highest quality product to the customer.

Requirements

• Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members.
• Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Collects and analyzes Leads Manufacturing process defect data Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
• Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
• Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
• Responsible for sustaining compliance and continuous improvement related to the manufacture of combination medical devices per 21 CFR part 4.

Benefits

• 401k Matching
• Retirement Plan
• Generous Paid Time Off