Patrice Stevens
Berkeley,CA
Summary
Quality and Regulatory Affairs professional with extensive experience in quality assurance for Class II and III medical devices, IVD products, and laboratory developed tests. Demonstrated ability to lead service-oriented teams while excelling in fast-paced environments. Proven track record in enhancing quality systems and ensuring regulatory compliance across regulated industries. Focused on reducing defects and driving continuous improvement initiatives.
Overview
17
17
years of professional experience
Work History
Sr. Manager Quality Assurance
Biocare Medical LLC
Pacheco
07.2024 - Current
- Direct daily operations of core QMS processes, including CAPA Management, Audit Readiness, Change Management, Supplier Quality, Customer Complaints, Planned Deviations and Document Control.
- Analyze quality control data to identify trends and root causes for process improvements.
- Train and mentor quality assurance staff on quality standards and best practices.
- Achieved six consecutive months of meeting Quality Objectives from Q4-2024 to Q1-2025.
- Collaborate with R&D to define quality criteria for new product launches.
- Support regulatory affairs with post-market surveillance activities, including corrections and recalls, PSUR and PMS reports.
- Partner with Materials Management to enhance Supplier Controls processes.
- Direct the preparation and execution of internal and compliance audits, achieving compliance with ISO, IVDR and MDSAP standards
- Supervise staff of 1 Quality Manager and 3 QA Specialists
QA Manager
Natera
San Carlos, USA
06.2023 - 05.2024
- Managed Quality Specialists & Engineers responsible for Quality Events, ensuring compliance of the Quality System through the following activities:
- Implemented process improvement projects for CAPA and Customer Complaints:
- Participated in Quality Audits as SME and back-room support for Quality Events:
- Coordinated the management of CAPAs and Audit Corrective Actions for all Natera products and Quality Audit findings - consistently achieving Quality Objective for CAPA TAT = 85%
- Non-conforming Material & Planned Deviations - 95% closure of records within 30 days.
- Quality Audit Management - Internal, Supplier/Pharma-partner & Notified Body - preparation and SME participation / Audit Co-host
- Led cross-functional team for implementing 'Fast-Track CAPA' process improvements - realizing a 20% increase in CAPA TAT metrics
- Developed and implemented a Quality plan for harmonizing customer complaints for IVD & Commercial products, reducing backlog by 15% in 3 months.
- Provided support for GMED Surveillance inspection.
- Managed Pre-Audit activity for CAP/CLIA & pharma-partner inspections by hosting audit breakout sessions based on audit agenda.
Supervisor Quality & Regulatory Affairs
Mindray North America
Mahwah, USA
12.2021 - 06.2023
- Directly responsible for implementation & ensuring compliance of the Quality System for Mindray North America contract manufacturing activity:
- CAPA administrator for all North American Quality investigations, Regulatory Affairs representative on the Material Review Board, Supervisor for Document Control activities.
- Developed CAPA, Customer Complaint and MDR metrics for Management Review
- Managed Post-Market Surveillance activities for Patient Monitoring, Legacy, and Anesthesia product lines, creating, approving and submitting Medical Device Reports for adverse event & product problem reporting.
- Coordinated complaint investigations with R&D, Technical Support, Field Service and Sales
- Supported the corrections and removal process including data collection and communication with FDA.
- Regulatory Affairs signatory for Change Notifications & Releases for promotional and advertising material, website updates, blogs, and social media pages
- Provide annual training on FDA Regulations, Health Canada, EU MDR, Complaint handling, GMP/GDP and CAPA investigations
- Contributed to the successful Medical Device Single Audit Plan (MDSAP) Certification
- Provide Audit 'War Room' management support during audit activities; SME for CAPA and MDR activity
Senior Engineer - Quality & Regulatory Affairs
Mindray North America
Mahwah, USA
04.2014 - 12.2021
- Management of the Document Control department: Responsible for maintaining the Internal/External documents including Change Control
- Managed the Document Control Harmonization project for 2 North American locations (NJ & CA)
- Oversee activity in the PowerDMS electronic training system for all Mindray North America personnel
- Supported the maintenance and control of DHRs, FHRs, product deviation (AIR), software releases, part number extension, NCMRs, Service Work Orders and Complaint records in Windchill PLM and SAP ERP System
- Direct supervision of 2 Quality Associates with Document Control and QA related tasks including complaint intake, calibration management and Quality Lab support.
- Implemented a Training Impact Assessment to be performed for all Initial Release documents to ensure compliance to training policies
- Coordinate and manage complaint investigations, MDR/Vigilance reporting, and servicing activity for Patient Monitoring & Legacy products.
- Serve as CAPA process owner/administrator including execution, tracking, and follow-up of investigation activities for Mindray North America
- Successfully implemented a Bi-annual CAPA Source Review for Continuous Improvement of the QMS
- Compiled failure analysis data in support of Shenzhen Mindray trending analysis for Patient Monitoring products
Senior Supplier Quality Engineer
Becton Dickinson & Co.
Franklin Lakes, USA
09.2012 - 05.2014
- Responsible for all Supplier Quality Management activities for BD-Medical Diabetes Care Worldwide (DCWW) including audit plan creation, supplier auditing, quality agreements, and SCAR management
- Responsible for Quality System and GMP evaluation of suppliers involved in pen needle, canula, and syringe manufacturing
- Facilitate Material Review Board meetings for global manufacturing facilities
- Managed the CAPA program for DCWW including facilitating monthly meetings & tracking CAPA timeliness from open to close
- Represented DCWW on the Supplier Management Action Team responsible for developing methods of continuous improvement in supplier evaluation.
Manager, Supplier Quality
St. Jude Medical Neuromodulation Division
Hackettstown, USA
04.2008 - 09.2012
- Responsible for Supplier Quality Management including vendor audits, supplier qualification, and approved vendor list maintenance for suppliers involved in the manufacturing of implantable neuromodulation devices (Class III)
- Managed, trained and developed the Receiving Inspection team consisting of 6 inspectors and 1 team leader, in inspection techniques, sampling plans and procedures/policies
- Oversee the NJ Internal Audit program, supervising 1 Quality Engineer
- Represent Quality on the Material Review Board for supplier-related nonconformities
- Review and Approve Engineering Change Notice documents as the Quality signatory
- Conducted Quality & Compliance, IPC600 & IPC610, GMP & GDP Training.
Education
MBA - Business Administration: Leadership and Organizational Health
University of Saint Mary
Leavenworth, KSBS - Interdisciplinary Studies: Physics & Math
New York Institute of Technology
Central Islip, NYSkills
- MDSAP certification
- FDA regulations
- Health Canada regulations
- EU/IVDR regulations
- ICH guidelines
- SAP ERP management
- CAP requirements
- CLIA standards
- ISO 9001 compliance
- ISO 13485 certification
- ISO 14971 risk management
- 21 CFR Part 11 compliance
- 21 CFR Part 803 reporting
- 21 CFR Part 806 notifications
- 21 CFR Part 820 quality systems
- Windchill management
- Trackwise usage
- JIRA project tracking
- Salesforce CRM expertise
- Dashboard and metrics development
- Quality Management Systems
- CAPA processes
- Internal auditing practices
- Document control systems
- Supplier quality assurance
- Process improvement strategies
- Cross-functional collaboration
References
References available upon request.
Timeline
Sr. Manager Quality Assurance
Biocare Medical LLC
07.2024 - Current
QA Manager
Natera
06.2023 - 05.2024
Supervisor Quality & Regulatory Affairs
Mindray North America
12.2021 - 06.2023
Senior Engineer - Quality & Regulatory Affairs
Mindray North America
04.2014 - 12.2021
Senior Supplier Quality Engineer
Becton Dickinson & Co.
09.2012 - 05.2014
Manager, Supplier Quality
St. Jude Medical Neuromodulation Division
04.2008 - 09.2012
MBA - Business Administration: Leadership and Organizational Health
University of Saint Mary
BS - Interdisciplinary Studies: Physics & Math
New York Institute of Technology
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