1. Provide three distinct professional services: Enable – Establish a culture of excellence to build in quality and avoid the costs of poor quality; Solve – Provide problem solving expertise and applying over 30 years of practical experiences to solve the organizations most critical issues; and Enable – Equip an organization’s employees through training and development.
2. Fractional or Permanent leadership role in Quality, Continuous Improvement, or Transformation leadership.

Competencies:
LEAN, Six SIgma, Continuous Improvement, Process Design, Product Development, Risk-based Quality Management, Customer Quality, QA, QC, Regulated Industries, Global Standards, Medical Devices, GMP, Life Sciences, Operations, Manufacturing, Product Services,

As a former FDA Investigator with 30-years of industry expertise, I prepare medical device and IVD companies to be ready for their next FDA inspection and Notified Body audit in the areas of compliance and quality.

- 30 years of experience in the creation, maintenance, remediation, and auditing of quality system and technical documentation for sterile and non-sterile medical device and in vitro diagnostics (IVD) companies from startup stage to fully commercial to ensure compliance with domestic and international quality and regulatory requirements.

- Support my clients by providing expertise in building, training, leading, and motivating high-functioning quality and regulatory compliance teams ensuring lasting knowledge transfer and inspection readiness.

- Talented internal and supplier auditor having practical experience with FDA inspection techniques, Quality System Regulation (QSR and QMSR), and on-site inspection procedures.

- Proficient in European and Global quality system standards such as ISO 13485, ISO 14971, ISO 9001, and the EU Medical Device Regulations (MD/AIMD, IVD) and associated Technical Documentation.

- Work extensively with contract design and manufacturing organizations (CDMO) to ensure that product is designed and manufactured in compliance with client, US, and international quality system requirements.

- FDA-483, Warning Letter, and Consent Decree responses and overall compliance.

Areas of Expertise:
FDA Regulations / QSR / QMSR
ISO 13485 Quality Management Systems
FDA Inspection Procedures
Quality System Inspection Technique (QSIT)
Quality Assurance
Quality Systems
Quality Control
Regulatory Compliance
Change Control
Culture Change
FDA Readiness and Remediation
Recall / Field Action
Complaint Handling
Internal, Supplier, Third Party Audits
Inspection and Testing
Process Control
Control of Nonconforming Product
Corrective Action (CA)
Preventive Action (PA)
Qualification and Validation
Design Control
Management Review
Project Management
Clinical Trials
Sterilization
Product Stability
Calibration
Preventative Maintenance
ISO 14971 Risk Management
ISO 9001 Quality Management Systems
ISO 19011 Audit Management
AIMD / MD / IVD / Biotechnology
Start-up companies
Class I, II, III Medical Devices
Expert Witness