Baylin Herington
Vista,CA
Summary
Dedicated Senior Quality Specialist and aspiring legal professional with 5 years of experience in the medical device industry. Seeking to leverage my expertise in quality management, regulatory compliance, and process improvement as I transition into a legal career. Passionate about healthcare law and eager to combine my expertise in regulatory compliance with legal advocacy.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Senior Quality Specialist
Becton, Dickinson and Company (BD)
San Diego, CA
07.2022 - Current
- Lead internal audits of the Quality Management System (QMS) to maintain compliance to applicable industry laws and regulations, improve processes to mitigate risk, and ensure products are safe and effective
- Support external audits, such as FDA Inspections, by assessing inspection readiness of key QMS areas to the audit criteria, defending QMS areas to the auditors, reviewing requested documents for suitability prior to delivery, and supporting corrective actions that address compliance gaps identified
- Serve as the Business Process Owner for Management Responsibility and Measurement, Analysis, & Improvement in support of the harmonization of QMS' across BD, which mitigates increased risks, complaints, and findings
- Gather and assess data for QMS metrics and information for KPIs, investigate deficiencies, and present findings to Top Management and relevant stakeholders to identify areas of improvement, address legal risks, and maintain compliance
- Lead cross-functional teams in implementing improvement projects that contribute to the suitability, adequacy, and effectiveness of the QMS. Improvement projects implemented have led to successes in 510k clearance, consent decrees, FDA 483s, and more
Lead Auditor and Quality Consultant
Immune, Inc
Carlsbad, CA
06.2019 - 06.2022
- Conducted internal audits, identified process gaps, and recommended corrective actions to ensure compliance with applicable regulations, laws, and standards
- Collaborated with cross-functional teams to ensure compliance with FDA regulations, ISO standards, and Good Manufacturing Practices (GMP)
- Developed and implemented corrective and preventive action (CAPA) plans
- Led training sessions on QMS and regulatory requirements for company employees
- Drafted and reviewed standard operating procedures (SOPs) to align with industry guidelines
Education
Bachelor of Arts - Communication Studies
University of California, Los Angeles
Los Angeles, CA06-2019
Skills
- Quality Management: ISO 13485:2016, CQA, FDA QSR, MDSAP
- Regulatory Compliance: 510(k) submissions, Consent Decrees, FDA 483s
- Auditing and Inspection: Internal audits, FDA inspections, Notified Body Audits
- Project Management: Experience leading cross-functional teams
- Communication: Strong written and verbal communication skill
- Legal Research: Familiarity with healthcare regulations and medical device law
Certification
- ISO 13485:2016
- ISO 9001:2015
- ASQ Certified Quality Auditor (CQA)
Timeline
Senior Quality Specialist
Becton, Dickinson and Company (BD)
07.2022 - Current
Lead Auditor and Quality Consultant
Immune, Inc
06.2019 - 06.2022
Bachelor of Arts - Communication Studies
University of California, Los Angeles
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