About TOLO Consulting LLC
Bridging together PMO & QMS Consulting Services
Executive Summary
TOLO Consulting LLC is a boutique management and quality consulting firm helping medical device, life science, and regulated organizations strengthen PMO governance, Quality Management Systems, supplier quality, compliance, digital capabilities, and operational execution.
TOLO Consulting LLC brings together program management, quality engineering, compliance expertise, and modern technology to help organizations improve visibility, strengthen controls, reduce risk, optimize resources, and deliver complex initiatives successfully.
Our approach is practical and execution-focused—helping clients improve how work is planned, governed, validated, controlled, and measured while supporting product quality, regulatory readiness, operational performance, and long-term growth.
About Lois Oler
Program Management Consultant
With over 15 years of collective experience in the medical device, medtech, and pharmaceutical industries, Lois leads large-scale quality, compliance, and business continuity initiatives with executive foresight and deep knowledge of industry, product, and quality practices.
Her expertise includes:
- Medical Device and Pharmaceutical Quality Programs
- Regulatory and Compliance Initiatives
- Business Continuity and Continuous Improvement
- Medical Device Design and Manufacturing Standards
- Senior Stakeholder Alignment and Consensus-Building
- Quality and Compliance Strategy Based on Business, Operating Model, and Industry Requirements
Lois builds consensus-driven relationships with senior-level stakeholders to align product, site, and segment objectives. She is valued for leading quality and compliance strategies that reflect business priorities, operating models, and industry requirements.
Credentials
- Six Sigma Black Belt (SSBB)
- Project Management Professional (PMP)
- Certified Quality Manager – Organizational Excellence (CQM-OE)
- Member of ASQ (American Society of Quality) Since 2015
What Clients Gain
Executive Visibility
Real-time insight into portfolios, programs, resources, and risks.
Improved Governance
Stronger frameworks, stage gates, and decision-making.
Better Portfolio Decisions
Prioritize the right work that drives strategic business outcomes.
Standardized Processes
Consistent, repeatable processes that increase efficiency and quality.
Resource Optimization
Optimize capacity, allocation, and utilization across the enterprise.
Automated Reporting
Reduce manual work with automated dashboards and executive reporting.
Reduced Manual Effort
Eliminate rework, spreadsheet sprawl, and disconnected data.
Faster Executive Decisions
Timely, accurate data empowers confident decision-making.
Stronger Organizational Maturity
Build PMO maturity and sustainable operating capability.
About Anthony Oler
Quality Systems Consultant
With more that 15 years of experience, Anthony Oler provides executive Quality Systems consulting services to medical device, biotechnology, pharmaceutical, and manufacturing organizations operating in highly regulated environments.
With extensive experience in Supplier Quality Engineering, Quality Management Systems, Manufacturing Quality, Regulatory Compliance, and Operational Excellence, he helps organizations strengthen quality systems, improve supplier performance, reduce regulatory risk, and support successful product development and manufacturing operations.
From FDA remediation and ISO 13485 compliance to supplier development, CAPA leadership, Design Controls, validation, and quality-system transformation, Anthony delivers practical, hands-on solutions that improve compliance and produce measurable operational results.
His expertise includes:
- Supplier Quality Engineering
- Quality Systems Remediation
- FDA and ISO 13485 Compliance
- Supplier Qualification and Development
- CAPA and SCAR Management
- Supplier Risk Management
- Design Controls and Design Transfer
- Change Control and Validation
- Internal and Supplier Audits
- Continuous Process Improvement
- Manufacturing Quality
- Regulatory Inspection Readiness
Anthony helps organizations build sustainable Quality Management Systems that strengthen compliance, improve supplier performance, reduce risk, and support long-term operational excellence.
Credentials
- Certified ISO 13485 Lead Auditor
- RABQSA Lead Auditor Training
- John C. Maxwell Leadership Certificate
- Minitab Statistical Analysis
- Investigation & Root Cause Analysis
- CAPA & Corrective Action Management
- Technical Writing & Investigation Documentation
What Clients Gain
Stronger Quality Systems
Robust, scalable QMS processes that support compliance, consistency, and operational control
Improved Audit Readiness
Better documentation, traceability, and process discipline for inspections and regulatory audits.
Reduced Compliance Risk
Proactive identification and mitigation of quality, regulatory, and operational risks.
Stronger Supplier Quality
Improved supplier controls, performance monitoring, issue resolution, and accountability.
Faster Issue Resolution
More effective CAPA, root cause analysis, and escalation processes that reduce recurring problems.
Standardized Quality Processes
Consistent, repeatable quality workflows that improve efficiency and reduce variability.
Greater Validation Confidence
Structured validation planning, execution, and documentation that supports compliant implementation.
Better Quality Visibility
Clear metrics, dashboards, and reporting that give leadership insight into quality performance and risk.
Sustainable Quality Maturity
Build stronger quality capabilities, governance, and continuous improvement across the organization.