Seeking advancement opportunities as a Quality Systems professional. Quality professional with 18+ years of experience in the medical device manufacturing industry, utilizing expertise and knowledge in implementing and managing effective quality improvement processes and structures in a corporate and regulated environment. 8+ years in a Quality Systems role, leading CAPA and action items, with expertise as an Subject Matter Expert (SME) utilizing Trackwise electronic Quality Management System. Highly focused and results-oriented in supporting intricate, deadline driven quality/compliance process and product related projects. ASQ-CQIA with expertise in ISO 13485 Quality Management Systems, internal and external audit support, and quality systems remediation. Ability to lead complex project teams and drive cross-functional collaboration within a team environment. Working knowledge of 21 CRF Parts 820, 210, & 211 and quality systems, including ISO 14971.
Star of Excellence Award Winner 2006, 2007, 2012
Work closely with a team of Engineers and multi-department project teams to drive rapid product and process improvement through multiple CAPA projects for the Diabetes business unit. Implement project management skills and capacity to achieve excellence in CAPA execution and compliance across cross-functional teams. Responsibilities include:
Responsible for developing and maintaining CAPA (Corrective and Preventive Action) quality systems and providing CAPA system support for the business unit.
Subject Matter Expert (SME) for Trackwise, electronic Quality Management system. Responsible for Software (UAT) script writing and testing and system validation during system upgrades and new releases.
Corporate Business Unit representative for Trackwise.
Leads biweekly CAPA Board reviews, Monthly Quality Reviews, and develops presentations for Quarterly Management Reviews.
Develops, maintains, and conducts CAPA process and Trackwise instructor led system training to cross-functional personnel as needed.
CAPA project management for both CAPA and Nonconformance's; Provides weekly, monthly and quarterly metrics to senior management and corporate.
Responsible for reviewing and approving all CAPA and Nonconformance records, including board reviews, risk assessments, root cause reports, action/effectiveness tasks, and CAPA closures.
Independently manage 70+ CAPA projects while ensuring timeliness in execution. .
Provide guidance, mentoring and coaching to CAPA owners throughout all phases of the CAPA process from initiation, investigation, action, effectiveness and including risk management and use of root cause analysis tools.
Drive rigor in project execution, phase gate process, and documentation.
Serve as SME for CAPA procedures, process and quality systems.
Primary CAPA support during internal and external audits.
Collaborates and works closely with audit team for internal observations escalating to CAPA.
Execution of CAPA remediation projects, including 483 responses and Quality Plans.
Good understanding of problem solving tools (e.g. DMAIC, Lean, Fishbone, 5 Why's, etc.) and statistical tools used in CAPA execution.
Experience with regulated environment; strong experience with documentation and formal engineering/product development process (i.e., Regulatory Submissions, Supplier Controls, Design Control, etc.).
Work multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
Ensure compliance to FDA Quality Systems Regulations, 21 CFR 820, ISO 13485, and ISO 14971.
Supervise 30+ employees for a Medical Device company focused on promoting health and extending life to those in need of Diabetes care. Focused on providing excellent sales/customer service experience while ensuring business sales growth and securing provider paid services. Responsibilities included:
Provide Leadership for the Diabetes Supply Order Services Insurance Verification team.
Developed training curriculum for the group, trending reports for forecasting, and team performance analysis.
Handle escalated calls; provide support, coaching, and feedback to employees on a regular basis.
Conduct weekly one on one mentoring meetings, maintain weekly KPI (key performance indicator) reports / data, and attend Supervisor/Management meetings.
Identify needs to update Decision Trees and work closely with Managed Markets to further improve first pass payment avoiding AR denials.
Completed Green Belt project that resulted in success as measured and monitored for effectiveness – obtain LS certification.
Conducted as lead to the department director for all data analysis, trending and monitoring of corrective / preventative actions (CAPA's in SOS).
Led the SOS CIT process and program under the direction of the department Director.
Chaired meetings for updates and or the launching of new SOS CIR's.
Participating in the creation and launching of the SOS CIT program where the results led to the first ever Star of Excellence Award obtained by the SOS department.
Point person for the operating system (Ontrac) for normal operations and monitoring as well as contingency plans when system challenges were presented.
Licensed Respiratory Care Practitioner through with the Respiratory Care Board of California. Worked for a Durable Medical Equipment (DME) company as an on-call and evening Respiratory Therapist providing care to patients in hospitals, nursing homes, and home-care. Serviced the LA area.
Manage and supervise a team of 20+ employees supporting the customer service call center.
Provide trending reports for forecasting of call volume, handle times, abandonment rates, etc. and team performance analysis.
Handled escalated calls, provided support, coaching, and feedback to employees on a regular basis.
Conducted weekly one on one mentoring meetings and maintained key performance metrics (KPIs) including quality monitoring.
Oversee clinicians and technicians in the 24 Hour Help Line. Monitor inbound and outbound calls related to all Medtronic Diabetes products (Pumps, Sets, Sensors, CGMS, etc.) to ensure quality of calls. Responsibilities included:
Provide educational feedback to technicians related to proper troubleshooting and documentation.
Identify improvements / weaknesses within department employees and work with supervisors to address problem areas (corrective actions).
Assist management with backup supervisor coverage.
Provide monthly reports on performance measurements & metrics.
Correct Service Notifications (SVNs) and sales orders as needed in SAP (electronic system) and implement solutions that prevent reoccurrence.
Revise departmental policies and procedures.
Responsible for handling and documenting customer service complaints for the 24Hr Helpline regarding Diabetic pumps and supplies.
Provide technical support, troubleshooting and education to patients, sales representatives, doctors, and nurses regarding sensors and CGM systems.
Educate other staff members on new products when needed.
Provide on call technical CGM/sensor support to doctors and nurses after hours.
Duties also included leading and executing on delegated special projects from the department manager.
Updated troubleshooting guides as needed.
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