Principal Quality Operations Engineer

POSITION SUMMARY:

The Principal Quality Operations Engineer provides enterprise technical leadership and quality oversight for the manufacturing infrastructure, critical facility systems, and utility systems that support compliant, reliable production. This position is accountable for defining the quality strategy, governance, and lifecycle expectations for these systems, including risk assessment, system and process validation, change control, program management, and continuous improvement. This includes ownership of the policies, procedures, controls, and quality practices that govern these systems. The role serves as a senior technical authority and trusted advisor, influencing cross-functional decisions to ensure facility and utility systems remain capable, controlled, inspection-ready, and aligned with applicable regulatory requirements and the AtriCure Quality Management System.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Lead the risk management program for critical facility and utility systems, including risk governance, escalation, timely investigation, and implementation of mitigations for identified risks, excursions, and quality issues.
• Define quality documentation expectations for facility and utility systems, including user needs, requirements, drawings, specifications, risk documentation, validation evidence, process controls, and related records.
• Establish quality strategies, Quality Plans, and validation master plans to guide large facility updates, utility changes, and critical system lifecycle management in alignment with AtriCure validation and quality system policies.
• Lead strategic quality and facility implementation programs from initiation through completion, including priorities, deliverables, resource alignment, stakeholder engagement, risk-based decision-making, and executive-level status communication.
• Advise cross-functional teams on facility change requests, including line moves, equipment moves, utility additions, and related changes that support production operations and require quality impact assessment.
• Provide technical authority for qualification and validation strategies applied to critical facility, utility, equipment, monitoring, and data systems, including development, execution, review, and approval of IQ/OQ/PQ documentation and lifecycle activities.
• Lead validation and data integrity practices for systems that capture critical facility and utility data, including dashboards, alert and action limits, trend monitoring, and escalation of conditions requiring investigation or corrective action.
• Drive development and improvement of quality system procedures and program controls governing critical facility and utility systems and supporting Quality Operations programs.
• Champion continuous improvement opportunities that increase efficiency, capacity, reliability, compliance, and operational readiness of critical facility and utility systems.
• Serve as a senior quality and engineering resource for facilities management, equipment qualification, process validation, preventive maintenance, and calibration activities related to Quality Operations-owned equipment.
• Influence Facilities, Quality Management, Operations, and other departments to assess system capacity, support company strategies, resolve complex issues, and maintain alignment with business and quality objectives.
• Define and communicate metrics that assess the health, performance, capacity, and compliance status of critical facility and utility systems, including status updates to quality, operational, and leadership forums.
• Represent Quality Operations during internal and external audits, including preparation, response, and follow-up activities related to critical facility and utility systems.
• Mentor Quality Operations engineers, build technical capability across the team, and provide trusted partnership and guidance to key stakeholders.
• Lead with expert knowledge of prescribed GMP, ISO, and GLP standards and ensure compliance with applicable domestic and international regulations, standards, and controls relevant to risk management, process validation, environmental monitoring, and related areas.

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

BASIC QUALIFICATIONS:

• Bachelor’s degree in engineering, or an equivalent combination of education, training, and experience.
• Minimum of 10 years of experience in the Medical Device Manufacturing Experience, or Manufacturing production and process control experience within a regulated industry.
• Experience with facility, utility, equipment, and/or process validation in a regulated manufacturing environment, preferably medical device manufacturing.
• Working knowledge of production and process controls, ISO 13485, GMP requirements, quality system procedures, and applicable validation standards and practices.
• Ability to develop and implement quality system programs, policies, procedures, technical documentation, validation master plans, and related controls.
• Demonstrated ability to lead cross-functional teams, influence alignment, facilitate decisions, and resolve complex technical and quality issues.
• Strong verbal, written, and presentation skills, including technical protocol and report development, stakeholder communication, and project status reporting.
• Ability to read and interpret technical specifications, blueprints, drawings, and related facility or engineering documentation.
• Strong problem-solving, troubleshooting, attention to detail, compliance orientation, and results-driven execution.
• Proficiency with computer-based systems, data entry, and basic data analysis or statistical tools.
• Ability to travel up to 15%.

PREFERRED QUALIFICATIONS:

• Experience in medical device manufacturing, quality operations, or quality management, preferably supporting sterile medical devices.
• Knowledge of cleanroom validation, contamination control, environmental monitoring, pest control, and facility-related safety practices.
• Facility engineering, facility design, construction, or manufacturing infrastructure experience in a regulated environment.
• Project management experience; PMP certification preferred.
• Technical file or CAD drawing management experience.
• FDA, ISO, or other regulatory audit experience.
• ASQ Certified Quality Engineer and/or ASQ Certified Six Sigma Black Belt certification.

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
• Ability to pass pre-employment drug screen and background check

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