SUMMARY

• A respected Medical Device leader able to bring change to challenging organizational situations.
• An effective project and people manager who implements changes to quality management policies, processes, and procedures, with expertise in the medical device industry.
• Proven expertise in using change management techniques to maximize productivity while achieving business and compliance objectives.
• A proactive collaborator able to direct teams and resolve complex issues at all organizational levels.

PROFESSIONAL EXPERIENCE

Quality Systems Associates

Confidential

Responsibilities:

• Lead Quality Consultant hired to remediate client complaint system. Implemented CAPAs to document all project activity.
• Updating all regulatory reporting procedures to meet global compliances requirement.
• Cross - functional team building for investigation, non-conformance remediation and updating risk analysis documentation.
• Major Medical Device Manufacturers - (Convatec, Philips Health Care, ConMed, Cook Medical, BioMerieux, Ulthera and Confidential, Zimmerbiomet).
• Regulatory assessments for DHF remediation project, review for regulatory requirements
• Wrote Comprehensive Complaint Investigation Reports (CCIR) for remediation batch investigation closures
• Interface with Sr. Management, Regulatory Agencies, Notified Bodies for remediation resolution
• Restructured complaints/corrective and preventative actions (CAPA) systems for Medical Device clients Class I, II and III products, IVD and Biologics
• Established standardized QS procedures
• Project Management
• Developed/conducted global programs to meet compliance requirements.
• Implemented continuous improvement (CI) efforts utilizing Lean/Six Sigma (DMAIC) to drive process and design improvement.
• Introduced methodology for tracking and trending.
• Familiar with Periodic Safety Update Reports (PSUR)
• Project manager for cross-functional teams.
• Coordinated recall activities, FDA updates, recall strategy
• Software Systems Mapping for user needs and user testing.
• Implementation of RoHS guidelines with traceability to DMRs
• Implemented of Field Service systems for improved compliant monitoring through
• ERP systems reconfiguration.
• Device returns/repair process improvements.
• Supplier Quality - Incoming inspection yield rate improvements.
• Internal Quality - First pass yield, NCR, internal audits
• Customer On-Time Delivery by required dates.
• Cost of Poor Quality - Reducing costs of scrap, rework, and returns.

Confidential, Elyria, Ohio

RAQA PMS Global Manager

Responsibilities:

• Global Complaint Manager. Under Consent Decree brought complaint process into compliance, which required a total QS restructure.
• Restructured complaint process/system for five North America sites (10K complaints/month).
• Hired/trained 50+ staff members, conducted audit and LEAN initiatives, and passed s audits.
• Focused on VOC strategy and change management teams.
• Reconfigured TrackWise system/Oracle, and trained 600+ staff for launch of new process/procedures.
• Implemented customer/field service procedures to meet customer needs.
• Managed recall team, recall strategies, s of destruction
• RoHS Compliance and product categorization for materials from China and Taiwan
• Collected data, established key quality metrics, and presented reports for management review.
• Built cross-functional team, meeting regulatory filing deadlines for FDA, MDD, new EUMDR, ISO, etc.

Confidential, Mahwah, N.J

Complaint Manager

Responsibilities:

• Implemented process improvements in global complaint initiatives and post-market surveillance (PMS) for $10B medical device company.
• Promoted common understanding and developed standardized complaint practice, meeting competent authority and business needs.
• Managed Confidential systems expenditures, global complaint platform, and regulatory/quality for seven divisions.
• Global systems integration/upgrades included ERP, TrackWise, and middleware.
• Managed regulatory reporting for global organization.
• Managed recall teams for 7 sites.
• Developed international partnership best practices for regulatory reporting and compliance issues in Europe, China, India, and Australia.
• Standardized service activity and non-conformance procedures for input to CAPA.
• Devised data strategy for multiple software systems to obtain common post-market metrics. Implemented data warehouse capabilities with IT to streamline data gathering/analysis for senior management.
• Accomplished Lean and RAQA compliance initiatives.

Confidential, Lakewood, Colo

Responsibilities:

• Coordinated/conducted quality- programs and implemented new global complaint handling system and e-filing.
• Managed regulatory compliance and quality implementation programs.
• Gained international experience in building complaint-handling teams to follow company/regulatory policy. Served as Americas Vigilance Manager for complaint handling dept.
• Performed medical device reporting (MDR) for all company foreign manufacturers and worldwide complaint handling process, reporting directly to senior management.
• Implemented quality trends for product improvement for North/South America.
• Gained FDA/ISO regulation experience and a strong medical device background.
• Held project management and staffing responsibility for $2.5M budget.
• Oversaw CAPA for five depts. with 400 employees. Coordinated projects, reported to management review teams and top management. Assisted in root cause analysis (RCA) and brought departments together to resolve systems issues.

Confidential, Aurora, Colo

Specialist/Quality Specialist

Responsibilities:

• Production Specialist. Designed, implemented, and documented technical protocols for production of Biomedical Blood Banking. Worked closely with management staff and inter-departmental reps to strengthen production operating procedures. Completed competency assessments for 130 SOPs, and helped to coordinate two major Confidential improvement projects.
• Document Control. Maintained department SOP and performance records and accomplished quarterly documentation audits.
• Safety Board. Followed FDA regulations, cGMP, and OSHA guidelines.
• QC Dept. Lab Technician. Performed bench work, QC sampling, qualified platelets, and operated lab equipment.

Confidential, Denver, Colo

Professional Research Assistant

Responsibilities:

• Clinical Research Assistant. Recruited Spanish/English-speaking subjects for a clinical trial/study to determine benefit of using Omega 3 in reducing premature births.
• Project Coordinator. Screened, recruited, monitored, and documented 600 subjects in a fast-paced, community hospital clinic setting.
• Lab Technician. Obtained/processed blood samples, following COMIRB, FDA, OSHA, lab, and hazardous materials safety guidelines. Worked directly with public/professional staff. Reported directly to Omega 3 food supplement manufacturer.