Monique Baskin
Bedford
Summary
Accomplished audiologist with a strong focus on post-market surveillance and regulatory compliance within the medical device industry. Proven track record of enhancing product quality through effective complaint management, safety analysis, and cross-functional collaboration, resulting in improved patient outcomes and compliance with evolving regulatory standards.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Consultant – Special Projects
Advanced Bionics
08.2021 - Current
- Conducted large-scale retrospective analysis of closed complaints, updated regulatory codes to maintain compliance with evolving requirements
- Reviewed and triaged thousands of customer service emails weekly, identified complaints and potential safety risks, ensured accurate and compliant documentation
- Developed and formalized a standardized process for reviewing customer service emails, improving consistency, efficiency, and compliance in complaint identification
- Analyzed and trended data to identify new issues and potential safety-related complaints.
- Covered maternity leave for Clinical Quality Assurance Team at Advanced Bionics. Reviewed and assessed product complaints and adverse events for regulatory reportability (e.g., Medical Device Reporting (MDR)), to ensure timely and accurate submissions.
Clinical Quality Assurance Specialist
Advanced Bionics LLC
Santa Clarita
01.2007 - 07.2020
- Reviewed high-volume field complaints to ensure completeness, regulatory reportability (e.g., MDR), and accurate documentation within the complaint handling system (SalesForce); initiated and tracked follow-up investigations to closure
- Collaborated 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
- Trained and mentored employees globally on complaint management systems and processes, improving data quality, consistency, and compliance across departments
- Contributed to multidisciplinary review boards by presenting and evaluating complex clinical cases, supporting risk assessment and decision-making for product performance and patient safety
- Analyzed 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
- Analyzed and trended data to identify new issues, potential safety related complaints and complex patient issues
- Identified and managed improvements to the complaint handling system, SalesForce, ensuring efficient and effective complaint handling processes.
- Assessed new products to determine appropriate symptoms and added related data to SalesForce and SAP. Performed risk assessments.
- Helped to develop and maintain procedures as needed to comply with regulatory and Quality System requirements.
- Supported notified body audits by FDA and TUV as a technical expert, providing critical insights and facilitating compliance.
Clinical Specialist, South East Region
Advanced Bionics LLC
Santa Clarita
03.2004 - 01.2007
- Provided on-site technical support to surgeons during initial and revision surgeries.
- Participated in initial activation appointments with clinic audiologists and performed follow-up consultations.
- Provided device troubleshooting for complex cases for adults and pediatrics. Collaborated with clinic audiologist to implement appropriate programming strategies for optimum results.
- Delivered product training to surgeons and audiologists
- Mentored and trained new clinical specialists
Cochlear Implant Coordinator
Owens Ear Center
Dallas
06.1999 - 03.2004
- Completed cochlear implant evaluations and programming for 250+ patients
- Performed diagnostic audiometric and vestibular assessments for adult and pediatric patients
- Provided intraoperative facial nerve monitoring during surgical procedures to support nerve identification and preservation
- Provided hearing aid dispensing services
- Collaborated as a co-investigator on 6 FDA clinical trials.
Education
Master of Science - Communication Disorders
University of Texas At Dallas
Dallas, TX06-1999
Bachelor of Science - Speech Language Pathology and Audiology
University of Texas at Dallas
Dallas, TX06-1997
Skills
- Medical device regulations expertise
- Salesforce experience
- CRM Management
- Analytical thinking
- Managing multiple priorities
- Effective communication
- Strong interpersonal abilities
- Counseling patients
Certification
- Certificate of Clinical Competency in Audiology (ASHA)
- Clinical Fellow – American Academy of Audiology (AAA)
Timeline
Consultant – Special Projects
Advanced Bionics
08.2021 - Current
Clinical Quality Assurance Specialist
Advanced Bionics LLC
01.2007 - 07.2020
Clinical Specialist, South East Region
Advanced Bionics LLC
03.2004 - 01.2007
Cochlear Implant Coordinator
Owens Ear Center
06.1999 - 03.2004
Master of Science - Communication Disorders
University of Texas At Dallas
Bachelor of Science - Speech Language Pathology and Audiology
University of Texas at Dallas