Monique Baskin
Bedford,NH
Summary
Clinical Quality Assurance Audiologist with over 20 years of experience in medical devices, specializing in post-market surveillance, complaint management, and regulatory reporting. Proven expertise in clinical data review, safety analysis, and Corrective and Preventative Action (CAPA) support within Class III device environments. Skilled in cross-functional collaboration and risk assessment to support product safety and compliance. Master of Science in Communication Disorders.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Clinical Quality Assurance Audiology Consultant (Special Projects)
Advanced Bionics, LLC
Santa Clarita, CA (Fully Remote)
08.2021 - Current
- Reviewed and triaged thousands of customer service emails weekly to identify general complaints and safety issues. Ensure accurate, compliant documentation in the complaint management system
- Performed large-scale retrospective analysis of closed complaints, assigning updated regulatory codes to ensure consistency and compliance with evolving requirements
- Review and assess product complaints and adverse events for regulatory reportability (e.g., Medical Device Reporting (MDR)), ensuring timely and accurate submissions
Clinical Quality Assurance Audiologist
Advanced Bionics, LLC
Santa Clarita, CA (Fully Remote)
01.2007 - 07.2020
- Review high-volume field complaints to ensure completeness, regulatory reportability (e.g., MDR), and accurate documentation within the complaint handling system; initiate and track follow-up investigations to closure
- Collaborate cross-functionally with Regulatory Affairs, Quality Assurance, Engineering, Clinical Research, and Marketing to evaluate complaint data, support investigations, and ensure alignment with regulatory and quality requirements
- Train and mentor employees on complaint management systems and processes, improving data quality, consistency, and compliance across departments
- Contribute to multidisciplinary review boards by presenting and evaluating complex clinical cases, supporting risk assessment and decision-making for product performance and patient safety
- Analyze large datasets of complaint trends and device failure modes to identify systemic issues, support Corrective and Preventative Action activities, and inform regulatory reporting and continuous quality improvement initiatives
Clinical Specialist, Southeast Region
Advanced Bionics, LLC
Santa Clarita, CA (Fully Remote)
03.2004 - 01.2007
- Delivered technical support and product training to surgeons and audiologists
- Identified regional sales barriers and implemented strategies to overcome objections
- Promoted best practices to drive measurable sales growth
- Communicated product value and competitive advantages effectively
- Analyzed hospital metrics including trends, market share, and forecasting
- Mentored and trained new clinical specialists
Cochlear Implant Coordinator
Owens Ear Center
Dallas, TX
06.1999 - 03.2004
- Performed diagnostic audiometric assessments for adult and pediatric patients
- Conducted vestibular evaluations
- Provided intraoperative facial nerve monitoring during surgical procedures to support nerve identification and preservation
- Provided hearing aid dispensing services
- Completed cochlear implant evaluations and programming for 250+ patients
- Served as co-investigator for 6 FDA clinical trials
- Dallas, TX
Education
Master of Science - Communication Disorders
University of Texas at Dallas
Dallas, TX01-1999
Bachelor of Science - Speech Language Pathology and Audiology
University of Texas at Dallas
Dallas, TX01-1997
Skills
- Clinical Data Review and Safety Analysis
- Post-Market Surveillance & Complaint Management
- Regulatory Reporting & Risk Assessment (Medical Device Reporting (MDR), FDA Compliance)
- Quality Systems, Corrective and Preventative Action (CAPA) Support & Trend Analysis
- Cross-Functional Collaboration & Stakeholder Training
Certification
- Certificate of Clinical Competency in Audiology (ASHA)
- Clinical Fellow – American Academy of Audiology
Timeline
Clinical Quality Assurance Audiology Consultant (Special Projects)
Advanced Bionics, LLC
08.2021 - Current
Clinical Quality Assurance Audiologist
Advanced Bionics, LLC
01.2007 - 07.2020
Clinical Specialist, Southeast Region
Advanced Bionics, LLC
03.2004 - 01.2007
Cochlear Implant Coordinator
Owens Ear Center
06.1999 - 03.2004
Bachelor of Science - Speech Language Pathology and Audiology
University of Texas at Dallas
Master of Science - Communication Disorders
University of Texas at Dallas