Wayne Seal
Director Quality Assurance Regulatory Affairs at Qlarity Imaging | Palm Beach, Florida, United States
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Wayne Seal serves as the Director of Quality Assurance Regulatory Affairs at Qlarity Imaging, where he leverages over 22 years of experience in the Toyota Production System to drive excellence in regulatory compliance and quality systems. His extensive expertise in Continuous Improvement Programs, particularly through methodologies such as Hoshin Kanri and Six Sigma, positions him as a pivotal leader in the organization. At Qlarity Imaging, Wayne leads the Global Regulatory Team (GRT) and oversees various sub-working groups focused on critical areas such as labeling and FDA submissions, as well as the transition to the EU Medical Device Regulation (MDR).
One of Wayne's key projects involves the Design History File (DHF) Remediation, where he conducts thorough gap assessments and revisions to ensure that all documentation aligns with stringent quality system and regulatory requirements. His comprehensive knowledge of ISO standards, FDA regulations, and Good Laboratory/Manufacturing Practices (GLP/GMP) enables him to develop robust regulatory strategies, particularly for 510(k) submissions of medical devices. Wayne has successfully led multiple 510(k) submissions, showcasing his ability to navigate complex regulatory landscapes while ensuring compliance and quality.
His skill set encompasses a diverse range of methodologies, including Statistical Process Control (SPC), Root Cause Analysis, and DMAIC, which he employs to enhance quality control and operational efficiency. Wayne's cross-functional team leadership fosters collaboration across departments, driving a culture of continuous improvement and regulatory excellence at Qlarity Imaging. His commitment to quality assurance not only ensures compliance but also supports the development of innovative medical devices that meet the highest industry standards.
Director Quality Assurance Regulatory Affairs at Qlarity Imaging in April 2022 to Present
Project Manager - Supplier Quality at Orthofix in January 2020 to May 2022
Project Manager at Pfizer-MMT in January 2020 to June 2021
Director Of Quality at Mack Technologies in January 2019 to January 2020
Director Of Quality at BBraun República Dominicana in January 2018 to December 2018
Lean - Continuous Improvement Manager at SKF USA Inc. in January 2015 to January 2018
Quality Remediation Consultant at Johnson & Johnson , Edwards Life Sciences, Baxter, Maquet-Getinge in January 2013 to January 2015
Director of Operations - Non Wovens Division at ACS Industries in February 2009 to January 2013
Director of Continuous Improvement - Contract at Eurostar - Paul Winston in December 2007 to February 2009
Director of Quality & Continuous Improvement at Covidien in January 2001 to January 2007
Military Officer at US Army in January 1990 to January 2000
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Quality Auditing
Troubleshooting
Project Management
Post Market Surveillance
Complaint Management
Complaint Investigations
Regulatory Policy
510(k)
DHF
Software Development Life Cycle (SDLC)
EU MDR
Regulatory Affairs
U.S. Food and Drug Administration (FDA)
Design Control
Lean Manufacturing
Six Sigma
SPC
Process Simulation
Lean Tools
Strategy
Hoshin Kanri
Culture Change
Manufacturing
Continuous Improvement
Kaizen
5S
Process Improvement
Value Stream Mapping
Operational Excellence
Root Cause Analysis
Quality System
Process Engineering
DMAIC
ISO
Product Development
Manufacturing Operations
Quality Control
TPM
Manufacturing Operations Management
Injection Molding
FMEA
Cross-functional Team Leadership
Validation
GMP
FDA
CAPA
Design of Experiments
Management
Business Process Improvement
Statistical Process Control (SPC)
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Discover more about Qlarity ImagingWhat is Wayne Seal email address?
Email Wayne Seal at [email protected] and [email protected]. This email is the most updated Wayne Seal email found in 2026.
What is Wayne Seal phone number?
Wayne Seal phone number is +19733665176.
How to contact Wayne Seal?
To contact Wayne Seal send an email to [email protected] or [email protected]. If you want to call Wayne Seal try calling on +19733665176. (updated on September 13, 2024)
What company does Wayne Seal work for?
Wayne Seal works for Qlarity Imaging
What is Wayne Seal's role at Qlarity Imaging?
Wayne Seal is Director Quality Assurance Regulatory Affairs
What industry does Wayne Seal work in?
Wayne Seal works in the Medical Equipment Manufacturing industry.
Wayne Seal Email Addresses
Wayne Seal Phone Numbers
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