Erick J.
No soliciting/ sales/ consulting inquiries.
- Role
- Director of Audit at Alcon
- Location
- Roanoke, TX, US
- LinkedIn followers
- 500 followers
About Erick J.
With an MBA from the University of St. Thomas - Opus College of Business, a Bachelor\'s in…
Experience
Director of Audit
Feb 2025 — Present · Fort Worth, TX, US
Lead global audits across Alcon’s pharmaceutical, surgical, and vision care businesses, covering manufacturing sites, distribution centers, R&D hubs, and corporate functions • Assess compliance and performance across sterile drug and device manufacturing, aseptic filling, ophthalmic implant production, packaging, labeling, and global distribution • Evaluate end-to-end quality system processes, including design control, risk management, CAPA, complaints, supplier management, and validation • Execute risk-based audits aligned with ISO 13485, 21 CFR 820/210/211, EU QMSR, MDSAP, Part 11, CSV, IT, and applicable health authority expectations • Deliver practical, business-aligned recommendations focused on systemic issues, operational efficiency, and regulatory preparedness • Operate independently; influence change through credibility, technical depth, and cross-functional collaboration with senior leadership • Manage, host, lead, and prepare global organization for Notified Body Audits.
Skills
- Fda
- Quality Control
- Gmp
- Quality System
- V&V
- Process Simulation
- Drug Eluting Stents
- Leadership Development
- Supplier Development
- Capital Equipment
- Medical Devices
- Capa
- Statistical Tools
- Root Cause Analysis
- Strategic Planning
- 21 Cfr Part 11
- Design Control
- Filtration
- Dfss
- Lean Six Sigma
- Six Sigma
- Quality Auditing
- Minitab
- Quality Management
- Processes Development
- Catheters
- Lean Manufacturing
- Project Management
- Spc
- Continuous Improvement
- Microsoft Office
- Validation
- Process Improvement
- Leadership
- Product Development
- R&D
- Str
- Iso 13485
- Iec 60601
- Fmea
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.