*Driving EU MDR Implementation and Certification, PRRC, Management Representative.*Manages FDA and Notified Body inspections/audits. Direct front/back room, FDA 483 response/remediation, Notified Body observation response/remediation experience.*Manages the development, implementation and maintenance of quality systems and activities. Leads the Quality System function for multiple sites to ensure quality system development and compliance with FDA’s Quality System Regulation, ISO 13485, MDD, MHLW and all other applicable requirements.* Develops, establishes and maintains quality system programs, architecture, content, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company standards necessary to maintain lasting consumer satisfaction.* 5 Sr Manager/Manager-level direct reports,19 reports total, in the functional areas of CAPA, Compliance, Configuration Management, Document Control, Training, Continuous Improvement, Post Market Surveillance, Reliability and Failure Analysis, Sustaining Engineering, and Metrics.*Leads engagement, inclusion, and diversity for department of 110 team members.

* Owns responsibility and authority to manage the development, implementation and maintenance of quality systems and activities. Leads the Quality System function to ensure quality system development and compliance with FDA’s Quality System Regulation, ISO 13485, MDD, MHLW and all other applicable requirements.* Develops, establishes and maintains quality system programs, architecture, content, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company standards necessary to maintain lasting consumer satisfaction.* 5 Sr Manager/Manager-level direct reports,19 reports total, in the functional areas of CAPA, Compliance, Configuration Management, Training, Continuous Improvement, and Metrics.

Director Quality Assurance-Partnered with Research & Development in implementing the New Product Introduction (NPI) Process to decrease cycle time in introducing new/improved medical devices while maximizing safety/ reliability/efficacy/compliance. Reviewed/approved design inputs/quality characteristics.-Managed risk activities, process validations, DFMEA’s/AFMEA’s/PFMEA’s, first articles, quality control plans, and sampling plans. Reviewed and approved Post Market Surveillance Plan.-Reviewed and approved Software Validation Protocols.-Reviewed and incorporated Complaints, CAPA, and Change Control Data into quality plans.-Created and/or reviewed specifications, drawings, quality criteria, SOP’s.-Review and approved supplier quality and documentation.-Created verification and validation testing, executed validation protocols and reports.-Reviewed and approved labeling and instructions for use (IFU’s).-Directed quality and regulatory activities for transfer projects. Developed quality plans.-Coordinated with Research & Development/Operations/Quality to ensure activities are completed for production/assembly of products and compliant to ISO 13485/ISO 14971/FDA 21 CFR 820.-Managed: Quality Engineering, Nonconformance, Inspection, Product Release, Gage Calibration, Environment Monitoring, Internal and External Audits. Managed FDA and BSi Audits.

As Sr QE, led the transfer of manufacturing from Jacksonville FL to Changzhou China and supported the quality systems at the Cranio Maxillofacial (CMF) Division of Biomet, a medical device company.

Owner - Managed all aspects of business including sales, marketing, customer service, finance, quality, compliance, supply chain, planning and human resources.Revenues averaged 2MM-4MM per year. Successfully managed safety, supplier, and insurance audits. Increased process efficiency by 35% and decreased costs by 20%.

Redesigned Quality Systems at Vistakon by removing ineffective, inefficient, bureaucratic policies and procedures.Once completed, software requirements were created and these quality systems were migrated to Reliance (an ETQ configurable software Quality System Platform)

Gulf War Veteran

Conducted destructive and non destructive testing of aluminum alloys and products.