Senior Quality & Facilities Operations Engineer

AtriCure, Inc.; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical & Dental beginning day 1 of em

401K plus match

30 days paid Parental Leave

Maternity leave

Volunteer Time off

Pet Insurance

On-site fitness center and cafeteria

Job summary

AtriCure, Inc. is seeking a Principal Quality Operations Engineer to provide senior leadership for the manufacturing infrastructure and utility systems.

You will define quality strategy, govern lifecycle activities, and ensure alignment with regulatory requirements and the AtriCure Quality Management System. You will guide cross-functional teams, drive risk management, validation, and continuous improvement while maintaining inspection readiness and compliant operations across facilities and

Qualifications

• Bachelor’s degree in engineering or equivalent.
• Minimum 10 years in Medical Device Manufacturing or regulated industry.
• Experience with facility, utility, equipment validation in a regulated environment.
• Knowledge of ISO 13485, GMP, quality system procedures and validation standards.
• Ability to lead cross-functional teams, influence alignment, facilitate decisions, and resolve complex issues.
• Strong written and presentation skills, including protocol and report development.

Responsibilities

• Lead risk management program for critical facility and utility systems, including governance and mitigations.
• Define quality documentation expectations for facility/utility systems and related records.
• Establish Quality Plans and validation master plans for large facility updates and lifecycle management.
• Lead strategic quality and facility implementation programs end-to-end.
• Advise cross-functional teams on facility changes with quality impact assessment.
• Provide technical authority for qualification/validation strategies and IQ/OQ/PQ documentation.
• Lead validation and data integrity practices for systems collecting critical data.
• Drive development and improvement of quality system procedures and program controls.
• Champion continuous improvement to increase efficiency, reliability, and compliance.
• Mentor Quality Operations engineers and guide stakeholders.
• Influence multiple departments to align with business and quality objectives.
• Define metrics to assess health and compliance of facility/utility systems.
• Represent Quality Operations during audits and follow-up activities.
• Lead with GMP, ISO, GLP standards and regulatory compliance.

Skills

Leadership

Cross-functional collaboration

Verbal and written communication

Problem solving

Attention to detail

Compliance awareness

Travel readiness

Education

Bachelor's degree in engineering

Tools

CAD drawing management

Job description

AtriCure, Inc. is seeking a Principal Quality Operations Engineer to provide senior leadership for the manufacturing infrastructure and utility systems.

You will define quality strategy, govern lifecycle activities, and ensure alignment with regulatory requirements and the AtriCure Quality Management System. You will guide cross-functional teams, drive risk management, validation, and continuous improvement while maintaining inspection readiness and compliant operations across facilities and