Quality Engineer

The Quality Engineer serves as the primary quality representative supporting manufacturing operations and product lifecycle management. This position will work closely with AtriCure Engineering, Manufacturing, Regulatory, and Supplier Quality to ensure manufacturing product quality, risk management, continuous improvement, and regulatory compliance of AtriCure products and processes.  This individual will have a technical foundation and must be able to lead and coordinate activities related to daily operations.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Provides daily Quality Engineering support of manufacturing operations where daily activities require working with collaborative cross-functional teams. Daily tasks require the timely addressing of product line issues through correction and prevention processes.
• With respect to direct line responsibility, the QE manages, and coordinates required activities from functions (ie. Engineering, Manufacturing, Supplier Quality, Inspection, Document Control) and processes (ie. NCR, Investigation, FMEAs, Rework, Deviations, CAPA)
• Chairs the MRB for respective product line.
• Leads and/or supports risk management activities including risk assessments, pFMEAs, health hazard evaluations, and implementation of risk control measures throughout the product lifecycle.
• Analyzes quality metrics, manufacturing trends, and process performance indicators to identify risks and drive improvement initiatives with cross-functional peers.
• Contributes to new product development and transfer by supporting Design Assurance (and NPD Teams) as required. Examples would include inspection/control plan development and the establishment of compliant production and process controls during production transfer
• Leads and/or supports protocol development, execution, review and approval activities for process validation, equipment qualification, test method validation, and manufacturing line transfers.
• Contributes to the development and implementation of quality system processes, including regulatory requirements, as applicable.
• Assists with 3rd party, internal, and external FDA and ISO audits, as necessary
• Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with little guidance from management, and resolves problems/conflicts.
• Performs other duties as assigned

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned