AtriCure, Inc. · 1 day ago
Clinical Quality Manager
Minnetonka, MN
Full-time
Onsite
Senior Level
5+ years expAtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Clinical Quality Manager will support the Clinical Affairs Organization in ensuring the quality and compliance of studies conducted within the clinical portfolio, driving clinical quality behaviors and cross-functional collaboration.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
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
Support and/or 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
Qualification
Required
Bachelor's degree with relevant medical, scientific/clinical experience
Minimum 5 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
Preferred
Master's degree with 3 years 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
Direct management of clinical quality personnel (Quality specialists), remote and onsite, providing work direction, guidance and mentoring
Benefits
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
Full access to our on-site fitness center and cafeteria
Company
AtriCure, Inc.
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide.
1001-5000 employees
H1B Sponsorship
AtriCure, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (7)
2022 (10)
2021 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$201MKey Investors
U.S. Venture Partners
2020-05-12Post Ipo Equity· $175M
2005-08-05IPO
2002-06-10Series Unknown· $21M
Leadership Team
Michael H. Carrel
President and Chief Executive Officer
Tamer Ibrahim
Vice President, Research & Technology
Recent News
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