Donald G. Email & Phone Number

United States

Responsibilities include: Managed Team of Pharmaceutical Compliance Investigators in the Medical Device, Pharmaceutical, and Biotechnical manufacturing industries to develop and/or remediate Quality/GxP Compliance systems to meet the FDA/ICH regulated requirements. Conduct in-depth compliance deviation investigations, examples: Solution Accountability, Active Pharmaceutical Ingredients, Country of Origin, Particulate, Combination Devices, Aseptic, Terminal Sterilization, Filter Integrity, etc. Technical writing of investigation reports. Provide various hands-on Quality Systems & GxP Compliance oversight of Manufacturing and Site Support departments. Identifies failure modes and related process improvements, facilitating teams and working independently to implement required changes. Utilize historical site data trends to work with operating departments to identify process improvement opportunities. Tracking of quality activities, metrics, CAPA tracking, etc. Perform detailed reviews of executed batch record documentation, including master and executed batch records (commercial products). Provides Quality and Regulatory Compliance support for Manufacturing Investigations, OOS Investigations, Process Operations, Rework and Re-inspection Protocols, Technical Reports, Equipment/Facilities Investigations.

Responsibilities include: Global supplier and converter management controls. Internal management controls. Monitoring control systems for compliance to documented procedures and process/ product requirements. Issue supplier corrective and preventative action to address non-conformances and improvement efforts. The creation of document controls by reviewing, writing/editing documentation to ISO 9001, ISO 13485, ISO 14001, & ISO 18001 Standards including - SOPs, WIs, RECs, IQPs, JHAs. The analysis of data using SPC techniques to improve the quality management system and reduce product/process variations. Manage CAPA system by investigating and developing corrective actions for Customer Complaints, NCRs, CARs, PARs, incidents and other failures. Develop Management, Customer and Supplier Audits & Quality Analysis reports. Internal training to promote employee awareness of Management System and Defect Awareness. Perform day-to day activities necessary for maintaining and improving the Management Systems. Conduct audits of all critical suppliers or converters. Participate as lead auditor, in Company internal and supplier qualification audits. Provide periodic updates on the status of assigned company improvement projects. Communicate with marketing and product managers to ensure that customer expectations are known and incorporated into control system documentation. Direct several Quality Assurance Inspectors & Technicians on daily duties including: Inspection, sampling, testing, and sterility certification documentation required for sterile product, and prioritizing incoming inspection of raw material.

Responsible for all aspects of Quality Assurance for an FDA regulated Surgical Instrumentation and Garment Reprocessing/Sterilization Facility. Responsibilities include: Management Reviews, Quality Management System Data Presentations, Customer Quality Management System Presentations, Internal Auditing, Audit planning and preparation, follow - up audits, Corrective & Preventive Actions, Root Cause Analysis, Customer Complaint Handling, Medical Device Reporting (MDR), Facility Standard Operating Procedure Training and Compliance, Monthly Business Reviews, Customer Visits, Implementation and Review of Standard Operating Procedures and Technical Work Instructions that comply FDA 21 CFR Part 820 and AAMI Standards. Direct facility Quality Control/Improvement program designed to ensure production of products that consistently meet established standards, customer expectations and reduce cost. Developed and implemented improvement program that reduced customer complaint by 68%.

Responsible all aspects of ISO 9001:2000 certified quality management system. Responsibilities include: Management Representative , Management Review QMS Data Presentations, Quality Management System Presentations and Training for Customers & Sales Personnel, Facilitate all ISO 9001:2000 surveillance & recertification audits, Internal/External Auditing, facilitating auditing team, develop annual audit schedule, audit preparation and planning, audit team selection, development and implementation of Internal Auditor Training Scheme, Scheduling and preparation of supplier audits, monitor supplier contracts for compliance with contractual terms, Corrective & Preventive Actions, Follow–up Audits, reporting QMS status to senior management, assist with improvements in operations and reductions in costs. Develop, implement and maintain standard operating procedures and technical work instructions that comply with ISO 9001:2008, ISO 13485 International Standards and FDA 21 CFR Part 820. Planned, developed and coordinate company wide Internal & External Equipment Calibration and Equipment Preventive Maintenance Program for company as well as On-Site Mobile Repair Vans. Planned, coordinated, and direct a quality control program designed to ensure production of products that consistently meet established standards and customer expectations. Developed and implemented a complete ISO 9001:2008 Quality Management System for medical repair company that achieved ISO 9001:2008 registration.

Responsible for all aspects of quality assurance and training in rigid endoscope repair laboratory as well as all medical device products including, rigid and flexible endoscope incoming evaluations, in-process quality testing, inspection, and final inspection. Develop, implement and maintain standard operating procedures. Develop, implement and maintain all repair work instructions, train all repair technicians on new repair procedures and quality tests. Oversee Adhesive and epoxy sterilization testing, customer service, technical support, training of field service representatives. Continually audit rigid endoscope documents as well as several addition product lines. Excellent working knowledge of all major OEM optical systems, Illumination Fiber Optics. Attend industry trade shows including, AORN, SGNA, and MDDI.

Responsible for all aspects of testing, repairing, and calibration of medical light sources. Responsible for calibration, operation and validations of Spectral Radiometer, Research and Development of illumination delivery prototypes, optical component testing, create Standard Operating Procedures, create manufacturing process instructions, create test set-ups and procedures, write test reports for Device Master Records, operation and general maintenance of Spectra-Physics class IV Argon Laser, operation of Andersen ETO sterilizer, maintain laboratory notebook, assist veterinarian surgeon in clinical site procedures. Assist mechanical and electrical engineers with testing of development products. Lead and direct auditing team on audits of all product documentation, audit team selection, develop and implement auditor training, conducting internal/external audits, schedule and prepare supplier audits, monitor supplier contracts for compliance with contractual terms, notified suppliers of non-conformances, make recommendations for corrective/preventive actions of unsatisfactory conditions, report findings to senior management, assist with improvements in operations and reductions in costs, perform spot checks and quality assurance inspections on works in progress.

Certified Mechanical Inspector

Certified Quality Technician

Certified Quality Auditor

Certified Cb/Spd Technician, Sterilization

Certified Quality Management System Auditor