EXECUTIVE SUMMARY

• Highly motivated, self - driven, accomplished manager wif considerable quality and regulatory compliance experience and a successful track record in global regulated medical device environment related to complaint handling, quality data analytics, post-market surveillance, recalls/corrections and corrective and preventive actions.

TECHNICAL SKILLS

• Knowledge & experience working in FDA, ISO 13485, MDSAP and EUMDR environments related to quality processes including change control, risk management, NCs, complaints, CAPA, internal audit and field safety actions.
• CQI/IRCA Certified Quality Management Systems Lead Auditor (ISO 13485:2016 and MDSAP) - NSF International, Oct 2017
• Lean Office and Service Certification - Univ of MI College of Engineering, Jun 2014
• Microsoft Tools (all wif strong emphasis), Workfront, eQMS SmartSolve, FDA e-submitter & Web Trader
• Former Certified Public Accountant
• Management, leadership, communication, teamwork, problem solving, analytical, organized, strategic thinking, time management, multi-tasking, writing, process mapping, lean processes, automating processes, customer service, budgeting, administration, presentations, advanced Microsoft Excel, advanced Microsoft Word, Microsoft PowerPoint, advanced Microsoft Visio, data analysis, reporting, KPIs, decision making, independent, continuous improvement, assertive, situationally aware, EU MDR noledge, ISO 13485, MDSAP, FDA, medical device

PROFESSIONAL EXPERIENCE

Confidential

QMS Program Manager

Responsibilities:

• Represented Complaints, Post-market Surveillance, Recalls and CAPA in 2018, 2019 and 2020 MDSAP audits wif zero non-conformances.
• Defined key metrics that underlie post-market surveillance and implemented improvements that demonstrated efficiencies of at least 15% as measured by the defined KPIs and enabled complaint handlers to eliminate a complaint closure backlog and maintain currency wif closures for the first time in over 10 years.
• Led and directed reduction of CAPA timeliness from Initiation to Implementation by 75% in 2019 (goal was a 25% reduction) and by an additional 50% in 2020, as of September (goal is a 25% reduction).
• Led and collaborated wif data analysts/business intelligence teams to develop and launch digital dashboards to help business triage and manage complaints/product issues, understand TEMPeffects of product/process improvements, and further drive sound business decisions.
• Developed local complaint handling process and supporting eQMS software which, after implementation, reduced the number of complaint handlers from eight to four.
• Led team to develop global complaint handling and post-market surveillance processes.
• Developed a high degree of technical proficiency related to the eQMS SmartSolve application, including configurations of workflows, forms, entities, saved searches, dashboards and reports for Complaints, Non-Conformance and CAPA modules.
• Implemented eQMS SmartSolve modules at inter-company locations in California, Canada, Mexico, China and Switzerland.
• Design, develop, implement and maintain a compliant and TEMPeffective post-market surveillance system, including communication wif the FDA for recalls, Medical Device Reports and periodic updates.
• Keep management informed of post-market feedback on products.
• Oversee the complaint handling process, including resources to ensure TEMPeffectiveness.
• Serve as the expert on post-market surveillance activities, ensuring support through the decision-making activity, closure and termination of issues.
• Drive continuous improvement and lean activities to improve efficiencies in post-market activities.
• Function as the champion for IT projects impacting the post-market function and/or systems.
• Oversee the complaint management team to ensure that all feedback mechanisms are captured and addressed in a timely manner.
• Function as the subject matter expert for post-market surveillance during external and internal audits.
• Serve as a voice of the customer.
• Continued next page

Confidential

QMS Program Manager

Responsibilities:

• Foster relationships wif site and global Customer Service, Operations, Marketing, Product Development, Quality Engineering and Supplier Quality.
• Ensure customer concerns are addressed to achieve a “green” quality rating from the customer’s perspective.
• Prepare post-market surveillance (PS) plans and publish PS reports.
• Lead regulatory reporting to ensure complaints are evaluated for regulatory reporting and submitted when appropriate and on time.
• Ensure complaints and adverse events requiring the attention of management are communicated.
• Participate in global complaint handling, field actions and reporting.
• Manage trends related to product complaints and relay information or concerns to upper management, including new product complaints.
• Maintain department procedures to reflect current regulatory requirements and department practices, and ensure that they are followed.
• Provide appropriate input to CAPA program and Management Review, as well as inputs to risk management and design/development teams.
• Ensure health hazard assessments are performed for regulatory reporting of product problems according to regional requirements.
• Manage, coordinate and direct all recall activities, including reporting and communicating wif regulatory bodies.
• Train and mentor CAPA owners in all required elements and best practices of CAPA, including containment, correction, corrective and preventive actions and TEMPeffectiveness checks.
• Ensure CAPA action plans are robust and executed promptly, wif the appropriate sense of urgency.
• Act as a Project Manager to drive CAPAs through closure wif internal CAPA owners and coordinators.
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
• Perform periodic trend analysis and corrective action TEMPeffectiveness measures of all quality system events and identify opportunities for improvement.
• Weekly monitoring and report out of CAPA statuses and timeliness.
• Independently prepare and present CAPA Review Board.
• Function as the subject matter expert for CAPA during external and internal audits.
• Support and maintain the eQMS SmartSolve application, on a global basis, including working wif a wide range of personnel and functions who use the application.
• Train SmartSolve users.
• Develop procedures and work instructions relative to incorporating SmartSolve into existing CAPA, NC and Complaint processes.
• Develop, configure and implement modules at company sites world-wide.
• Administrative responsibility for the SmartSolve application, including user, role, right, profile, user license and data table management and maintenance.
• Creation and maintenance of dashboards, saved searches and reports.
• Lead, manage, mentor and coach five direct reports, including four complaint handlers and one data analyst.
• Lead and manage, and collaborate wif, CAPA owners and coordinators.
• Independently prepare Monthly and Quarterly complaint, post-market, recall and CAPA metrics and reporting.
• Establish strategic direction, goals and objectives that align wif global and site priorities.
• Budget forecasts, resource allocation, performance reviews.

Confidential

Quality Data Analyst

Responsibilities:

• All metrics and reporting related to all aspects of the Quality Management System: Complaints, Non-conformances, Deviations, CAPA, Supplier Quality, Internal Audits, Training, Document Control, Quality Control, deviations, scrap and production, including analysis thereof to identify trends or other indicators of special cause variation.
• Generate complaint rates and cost per complaint.
• Gather and organize complaint data from information reported by the end user, including troubleshooting and data from evaluated product in support of investigations to root cause and to identify negative trends or other indicators of special cause variation needing further analysis by Quality Engineering.
• Prepare/analyze data to ensure timely execution of CAPAs.
• Gather and analyze quality data to support the determination of TEMPeffectiveness of implemented corrective actions.
• Gather/analyze quality data to support risk management.
• Compile and monitor Cost of Quality.
• Developed the complaint handling process from the ground up.
• Assumed primary responsibility for the transition from a paper-based complaint system to an electronic system, to the point of becoming the subject matter expert.
• Solely handled the reportable and potentially reportable, complaints, which required following up wif customers, coordinating wif clinical, regulatory and engineering personnel, assessing for reportability and filing regulatory reports, as applicable.
• Served as unofficial lead of the complaint handling unit, as the “go to” person for both fellow complaint handlers and the complaint handling supervisor.