Associate Director, Quality

• Apr 2022 - Present

Senior Quality Consultant

• Aug 2021 - Apr 2022

• Advise top management at a Fortune 200 company and implemented best practices related to supplier quality processes, audits, and risk management.• Perform critical supplier evaluations for new product development projects• Examine and retooled a supplier quality system to be risk-based and functionally compliant• Analyze and streamlined outdated procedures to be more efficient and operational across multiple business units

Manager, Corporate Quality

• Jul 2018 - Jul 2021

• Responsible for management and implementation of CAPA, Internal Audit, Configuration Management, Receiving Inspection and general Post-Market Surveillance systems• Managed and facilitated the company-wide, global implementation of ISO 13485:2016• Initiated and led full-scale QMS improvement project• Coordinated UDI implementation into overall QMS• Developed structure and process workflow for dedicated failure analysis team• Designed and organized the implementation of a Risk-Based Complaint processing system• Representative for Quality Systems in design development and change management program duties• Supporting integration of new eQMS system as a subject matter expert• Lead contact and front room facilitator for all external regulatory audits

Quality Assurance Specialist

• Dec 2015 - Jul 2018

Responsible for managing Quality related projects and supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR/Vigilance submission, which includes Non-Conformance Investigations, CAPA processes, Field Actions, Documentation Management and Metrics. I am responsible for the oversight and direct support of technical evaluations and investigatory tasks required for complaint processing/closure. I communicate regularly with Engineering, Manufacturing, Marketing, Sales, Customer Experience and other functional experts as needed to ensure swift project completion and thorough investigations. Trained on latest ISO 9001:2015 and ISO 13485:2016 changes.Key Achievements & Responsibilities:• Currently managing global program transition of international ISO 13485:2016 regulatory standard.• Executed the implementation of a Risk-Based Customer Complaint processing system.• Coordinated and assisted with an extensive update to the company website to improve ease of use and standardized compliance.• Supported company Kaizen event as a Subject Matter Expert to improve customer Service Out Of Box (SOOB) failures.• Plan and perform quality system audits in accordance with documented procedures.• Host monthly metric, CAPA and Audit Finding meetings with a cross-functional teams• Perform customer complaint review, investigations and problem reporting to regulatory agencies.• Process owner and coordinator for corrective and preventive action system (CAPA)• Managing Continuous Improvement projects utilizing Six Sigma and Lean process methodologies.• Managing CAPA's and Audit Findings• Performing internal audits and supporting/coordinating external audits• Support the conduct, documentation, and closure of field correction and removal (recall) activities when needed.

Associate Post-Market Surveillance Specialist

• Feb 2012 - Dec 2015

• Investigate and process customer reported Class 3 medical device failures that occur in the field. • Contact customers to ensure device failure resolution.• Report and track potential trending device failures for Design Engineering and CAPA related actions.• Created, supervised and directed document control and electronic request system for FDA regulatory audit.• Continue to supervise the document and data electronic request system for FDA regulatory audits.• Assist with special Quality Assurance projects and program implementations.

Associate Continuous Improvement Analyst

• Sep 2008 - Jul 2011

Physio-Control is a medical device company that specializes in designing and manufacturing defibrillators.Accomplistments and Responsibilities included:• Created, supervised and directed document control and electronic request system for FDA regulatory audits.• Managed process, schedules and execution of action items resulting from weekly Quality Review Board decisions.• On-going process implementation to meet company standards and project initiatives.• Coordinated and managed project to streamline process for selecting and integrating new suppliers.• Produced and presented quality system metrics for quarterly senior management review meetings.

Customer Service Representative

• 2007 - 2008

Customer relations including setup, troubleshooting and management of customer accounts.• Efficiently initiated electric and natural gas service while building strong customer relationships• Effectively assigned time payment arrangements balancing customer needs and company policies• Aptly addressed customer needs regarding reconnections, maintenance and emergency situations• Provided customer education regarding account activity Customer relations including setup, troubleshooting and management of customer accounts.• Efficiently initiated electric and natural gas service while building strong customer relationships• Effectively assigned time payment arrangements balancing customer needs and company policies• Aptly addressed customer needs regarding reconnections, maintenance and emergency situations• Provided customer education regarding account activity

Office Assistant

• 2004 - 2007

Kurve Technology Inc. designs and develops innovative and ground-breaking medical devices.• Contacted agencies, organizations and associations via telephone successfully increasing funding• Organized application process and accurately completing all appropriate paper work• General office assistance Kurve Technology Inc. designs and develops innovative and ground-breaking medical devices.• Contacted agencies, organizations and associations via telephone successfully increasing funding• Organized application process and accurately completing all appropriate paper work• General office assistance