Senior Quality Operations Engineer: Facility & Validation

AtriCure, Inc.; Mason (OH); On-site; USD 120,000 - 190,000; Full time

Job summary

AtriCure, Inc. is seeking a Principal Quality Operations Engineer to provide enterprise technical leadership for manufacturing infrastructure, critical facility systems, and utility systems, ensuring compliance with GMP, ISO, and GLP standards.

The role owns quality strategy, validation, change control, and lifecycle activities, while guiding cross-functional teams to achieve inspection readiness and reliable production.

Qualifications

• Bachelor's degree in engineering or equivalent.
• Minimum 10 years in medical device manufacturing or regulated industry.
• Experience with facility/utility/equipment validation.
• Knowledge of ISO 13485, GMP, and quality system procedures.
• Proven ability to lead cross-functional teams.

Responsibilities

• Lead risk governance for critical facility and utility systems.
• Define quality documentation expectations for facility and utility systems.
• Establish quality strategies and validation master plans for large facility updates.
• Lead strategic quality and facility implementation programs from initiation to completion.
• Advise cross-functional teams on facility changes and quality impact assessments.
• Provide technical authority for IQ/OQ/PQ documentation and lifecycle activities.
• Lead validation and data integrity practices for critical facility data.
• Drive development of quality system procedures for facilities and utilities.
• Champion continuous improvement to increase efficiency and reliability.
• Mentor Quality Operations engineers and guide stakeholders.
• Influence various departments to align with business and quality objectives.
• Define and communicate metrics for system health and compliance.
• Represent Quality Operations during audits.

Skills

Quality systems

Regulatory compliance

Risk management

Validation

Cross-functional leadership

Process improvement

Documentation & reporting

Data analysis

Problem-solving

Project management

Education

Bachelor's degree in engineering

Tools

PMP certification

CAD drawing management

Statistical tools

Job description

AtriCure, Inc. is seeking a Principal Quality Operations Engineer to provide enterprise technical leadership for manufacturing infrastructure, critical facility systems, and utility systems, ensuring compliance with GMP, ISO, and GLP standards.

The role owns quality strategy, validation, change control, and lifecycle activities, while guiding cross-functional teams to achieve inspection readiness and reliable production.