Michael W. Email & Phone Number

United States

Bloomington, Indiana Area

• Complete complaint investigations in accordance with Client QMS and 21 CFR • Create and maintain curriculum, job aides and training records for a team of investigators.• Perform quality engineering risk assessments (FMEA).• Provide data to CAPA review board based on risk assessments.• Work directly with QA manager on continuous improvement initiative including quality system protocol revisions and consulted on implementation of CGMP and CGDP programs.

Phoenix, Arizona Area

· Establish investigation procedure to match interim protocol for complaint backlog· Develop job aides and tools to improve and streamline investigation process· Complete full investigations of product failures with trending analysis· Establish intake procedures to improve initial information capture

• Perform final review of product investigations to ensure completeness and regulatory compliance• Complete full investigations of product failures with trending analysis• Analyze complaints to determine MDR reportability in accordance with 21 CFR 820• Perform 3500A MDR Medical Device Reporting per 21 CFR 803• Remediate complaint files and Trackwise complaint records per 21 CFR 820• Regulatory consultant on UDI / GUDID compliance initiative• Research 510k’s and legacy documentation to determine regulatory licensing status for a 5,000 product portfolio• Reconcile and integrate product and regulatory information from a major corporate acquisition into Convatec quality systems• Assist with protocol and work instruction development and implementation• Create and implement job aids and training materials

Ohio

• Analyzed complaints to determine MDR reportability in accordance with 21 CFR 820• Performed 3500A MDR Medical Device Reporting per 21 CFR 803• Maintained and updated complaint and filing information in a dual Oracle/Trackwise system per 21 CFR 820• Assembled metrics reports and analysis to track progress of backlog remediation.• Created and implemented training modules relating to complaint handling, filing, investigation, complaint closure• Participated in evaluation groups to streamline the reportability decision process in accordance with 21 CFR 820

Westlake, Oh