Clinical Quality Manager

Clinical Quality Manager

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

POSITION SUMMARY :

The Clinical Quality Manager will support the Clinical Affairs Organization in ensuring the quality and compliance of studies conducted within the clinical portfolio. This role will be responsible for leading and proactively driving clinical quality behaviors, accountability, and cross-functional collaboration with respect to clinical quality assurance activities. The Clinical Quality Manager will also drive continuous improvement in adherence to agency regulations and standards, GCP, global industry guidelines, and AtriCure policies, procedures and processes for the conduct of clinical studies.

ESSENTIAL FUNCTIONS OF THE POSITION :

• Maintain and monitor AtriCure clinical processes and procedures for compliance with applicable regulations and industry best practices, driving clinical process improvement projects and initiatives for development, enhancement and implementation of controlled documents.
• Lead implementation of Quality processes including audit and inspection readiness activities to ensure clinical studies are conducted in compliance with relevant AtriCure policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
• Support and / or represents the company in clinical audits, coordinating responses with Regulatory Affairs, AtriCure Quality, Scientific Affairs, legal, and vendors as applicable.
• Identify non-conformance with requirements, providing suitable recommendations and facilitating ongoing quality improvements using optimal methodologies while maintaining compliance with applicable study protocols, and global regulatory requirements as applicable.
• Lead and contribute to the development and maintenance of Clinical Quality metrics for input into process improvement initiatives and / or presentation to study management and leadership teams.
• Lead the development and delivery of clinical quality compliance related training to internal functional groups, providing guidance and ensuring study teams are following targeted SOPs / WIs during a study.
• Assist in development of GCP audit strategies across clinical programs and / or studies.
• Plans, develops and manages audits of clinical vendors, clinical sites, and / or internal clinical processes, and manages pre / post inspection follow-up activities.
• Perform reviews of clinical study documentation for data integrity and compliance with GCP guidelines and regulations.
• Assure appropriate oversight of Clinical Software Validation and Supplier / Vendor Qualification / Management and Approved Supplier Lists in accordance with SOPs as applicable.
• Lead and / or supports harmonization of processes and procedures across the Clinical, Regulatory, Scientific and Medical Affairs Organization as needed, including AtriCure Registry Studies.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION :

BASIC QUALIFICATIONS :

PREFERRED QUALIFICATIONS :

OTHER REQUIREMENTS :

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.