AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. 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. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.


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 Sr. 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 (e.g. Clinical Programs, Scientific Affairs, AtriCure Quality, Regulatory Affairs, Medical Directors, Study Teams, Investigational Trial Sites, and external vendors) with respect to clinical quality assurance activities. The Sr. 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 (e.g. Standard Operating Procedures (SOPs), Work Instructions (WI) and Templates).
• 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.
• Represents the company in clinical audits, coordinating responses with Regulatory Affairs, AtriCure Quality, Scientific Affairs, legal, and vendors as applicable.
• Identifies 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 (e.g. reports, corrective actions) as applicable.
• Perform reviews of clinical study documentation for data integrity and compliance with GCP guidelines and regulations, including quality control checks of the eTMF to ensure it is inspection ready.
• Assure appropriate oversight of Clinical Software Validation and Supplier/Vendor Qualification/Management and Approved Supplier Lists in accordance with SOPs as applicable.
• Leads and/or supports audits, risk assessments and inspections of clinical study vendors. Work with vendors and support personnel in eliminating issues via root cause analysis techniques to continuously review and improve existing processes.
• Leads, develops and/or implements inspection readiness programs (e.g. BIMO) and associated activities working closely with cross-functional team members to drive audit/inspection readiness activities and clinical responses, driving process improvements as needed.
• Responsible for the development and operational implementation of quality assurance initiatives, process improvements, and sound quality principles and practices.
• Leads 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:

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

BASIC QUALIFICATIONS:

• Bachelor's degree with relevant medical, scientific/clinical experience.
• Minimum 10 years of experience working in medical device (preferred), pharma, biotech clinical quality assurance/operations roles.
• Direct experience with health authority inspections such as US FDA BIMO inspections (Sponsors, CROs and/or Clinical Investigator sites), BSI inspections etc.
• Experience preparing investigational sites for inspection by regulatory agencies.
• Experience in auditing clinical vendors, CROs and internal clinical programs.
• Exceptional written and verbal communication and influencing skills, with the ability to communicate effectively at all levels of the organization including with external regulatory agencies.
• Strong people leadership and talent development skills.
• Demonstrated strategic thinking and leadership skills.
• Independently motivated, detail oriented, strong analytical and problem-solving skills, with a focus on risk management and continuous improvement.
• In-depth knowledge of guidelines and FDA/ISO regulations for pre- and post-market clinical trials.
• Previous experience of CTMS, eTMF and EDC systems.
• Skilled at working effectively in a collaborative team environment.
• Proficient in Microsoft Office skills, including Excel, Word, and Power Point.
• Ability to exercise judgment and determine appropriate action.
• Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment and manage deadlines.
• 25% travel possibility

PREFERRED QUALIFICATIONS:

• Master's degree with relevant medical, scientific/clinical experience in a GCP practice area; Clinical Quality Assurance or similar role preferred.
• Global Clinical Quality experience (e.g. APAC, EU, UK, etc.)
• Expert CAPA knowledge and experience
• Previous experience working as a Clinical Quality Manager within a cardiology therapeutic area

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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AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).