Kimberly Meade
Executive Director, Quality & Regulatory Compliance at ProSciento, Inc.
- Role
- Executive Director Quality & Regulatory Compliance at ProSciento, Inc.
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Kimberly Meade
Extensive experience in Quality Assurance discipline, demonstrated skill and experience in project management, designing, implementing, and monitoring control systems. Excellent interpersonal skills, self-motivated and able to work in a complex environment. Facilitated development and implementation of programs in order to optimize product, process and system level output.Specialties: Project Management, Customer Service, Quality Management System Internal Audits, auditor training and audit schedule deployment, including FDA 21 CFR Part 820, ISO 13485 Compliance, Complaint processing, Supplier Quality Management, Receiving Inspection and MRB, Process SPC, Failure/Root Cause Analysis and Corrective and Preventive Action (CAPA), Calibration, Field Returns and Customer interface on Quality related issues.
Experience
Executive Director Quality & Regulatory Compliance
Jun 2023 — Present · San Diego, CA, US
Education
UC San Diego Extended Studies
Professional Certificate - Quality Assurance and Control, Drugs and Biologics
2016 — 2017
UC San Diego Extended Studies
Professional Certificate - Clinical Trials Administration
2020 — 2020
UC San Diego Extended Studies
Professional Certification, Competitive Manufacturing
1995 — 1997
UC San Diego Extended Studies
Professional Certificate, Quality Management
2000 — 2001
UC San Diego Extended Studies
Professional Certificate, Project Management
2001 — 2002
California State University-Dominguez Hills
MSQA, Service and Health Care
2010 — 2013
National University
B.A., Business Administration
1985 — 1987
Skills
- Product Development
- Dmaic
- Regulatory Submissions
- Spc
- Iso 9001
- Change Control
- Quality Control
- Gmp
- Employee Training
- 21 Cfr Part 11
- Design Control
- Program Management
- Continuous Improvement
- 21 Cfr
- Six Sigma
- Quality Auditing
- Lean Manufacturing
- Medical Devices
- Capa
- Iso 9000
- Manufacturing
- Failure Analysis
- 21 Cfr Part 820
- Iso Standards
- Quality System
- Quality Systems
- V&V
- Statistical Process Control (Spc)
- Project Management
- Fmea
- Root Cause Analysis
- Quality Management
- Iso
- Fda
- Regulatory Affairs
- Iso 13485
- Quality Assurance
- Corrective and Preventive Action (Capa)
- Validation
- Cross-Functional Team Leadership
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