Quality & Compliance Services
Consultant Name
Dale Thanig
Categories
- Law & Regulatory Compliance
- Engineering & Manufacturing Support
Contact Information
Address
2834 Alydar Way
Cottage Grove, WI 53527
Phone
608 469-4406
608 469-4406 (mobile)
Web
Introduction
Dale Thanig has over 25 years of achievements in designing and implementing quality systems and operational excellence for high-tech global companies. He has applied best practices and simplified approaches for quality system and management practices to analytical, medical device and in vitro diagnostic products while ensuring compliance with ISO 13485, ISO 9001, FDA and international regulations.
Dale has collaborated with FDA, Notified Bodies, Suppliers and Customers in quality system assessments and improvement projects. He has extensive experience designing strategic quality improvement plans, conducting Quality System Audits and Management Reviews, developing Supplier and OEM quality programs, preparing for FDA inspections, driving conducting acquisition due diligence/integration and delivering quality training.
Services
Quality System development and auditing
FDA Inspection preparation and management
FDA 510(k) submissions
ISO 13485, and ISO 9001 certification
Medical Device Directive (MDD) and Canadian Medical Device (CMDR) compliance
Quality Improvement Programs and Quality Planning
Interpreting and integrating the requirements of standards and regulations into effective quality system procedures, product design, process controls and management practices.
Background Information
Employment history - quality and operations leadership positions with the following firms:
Varian Associates Palo Alto, CA - Radiotherapy linear accelerators
Nicolet Instruments Madison, WI - FTIR Spectrometers, EEG/EMG
Dynatech Labs Chantilly, VA - In vitro diagnostics
Datex-Ohmeda Louisville, CO - Pulse oximeters, Gas monitors
GE Healthcare Madison, WI - Anesthesia machines, patient monitors
Guest lecturer at Marquette University School of Biomedical Engineering and the Medical College of Wisconsin.
Commissioned officer on the Navy’s Nuclear Power submarines, qualifying as officer of the Deck and Chief Engineering Officer.
BS in mathematics from Marquette University; graduate work in statistics and reliability engineering at the University of Arizona. ASQ certification as a Quality Engineer.
Former Member of the Board of Examiners for the Malcolm Baldrige National Quality Award.