PROFESSIONAL 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.

Education: University of Denver Colorado May 2001

BS/ Pre Med, Chemistry

SKILL SUMMARY

Areas of Expertise

Program and Project Management

Quality System Implementation

MDR and 2017/EUMDR Revised Reporting Regulations

Software System Development Methodologies

ERP systems reconfiguration

Staff Planning and Management

FDA, ISO, MDD, MDV, TUV Regulations

Medical Device Mergers and Acquisitions

Lean Business Process

RoHS Compliance and Product Categorization

DHF Remediation, Root Cause Analysis

Budgeting and Estimation techniques

Technical Writing

Complaints, CAPA, Non-Conformance, Recall

Front Room Audit Experience

Six Sigma Certified – Green Belt

IBM /Watson Health March 2022- June 30, 2022

Merge Healthcare July 1, 2022 – July 24, 2023

Hartland, WI

QE III / QA III

Assigned to CAPA management team to complete non-conformance and CAPA documentation using the JIRA

Records System.

Maintained oversight of the Environmental Controls monthly activities.

Maintain, review and approval of Verification and Validation Process controls System.

Jan 2023 – Assigned to Supplier Management Team to cross train on Supplier Quality process. Review and approve suppliers’ qualifications, certifications, and systems in order to qualify for the approved supplier list.

Independent Quality Consultant -

Quality Systems Associates LLC-Owner

Maetrics, Indianapolis, Ind. (April 2014 – Feb 2017) (Nov 2019-March 2020) Convatec, BioMeieux, Cook Medical

Quality Hub, Orlando Fl. (Feb 2017- Feb 2018) ConMed, Ulthera, Tosoh, Pfizer (Oct 2021-Current)

Modis/Addeco -(Feb 2018-June 2018) Philips, Smiths Medical

Advanced Clinical (June 2018 – Sept 2019) Zimmerbiomet

Maetrics – DHF remediation (Sept 19 – March 2020) Philips, Convatec

April 2014 – March- 2022

Panzer Solutions – (Feb 2021 – Oct 2021) Jabil

Quality Systems collaborating on small projects for Quality Confidential - currently

Systems: 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 Stryker, Zimmerbiomet, Jabil, Pfizer).

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/Program Management/ QE III

oManaged large Quality Systems remediation, complaint system remediation, backlogs

oLead large global projects (Stryker, Zimmer Biomet, Philips).

oManaged Design History file remediation to be compliant with 2017/EUMDR regulations

oDeveloped/conducted global training programs to meet compliance requirements.

oImplemented continuous improvement (CI) efforts utilizing Lean/Six Sigma (DMAIC) to drive process and design improvement.

oIntroduced methodology for tracking and trending.

oFamiliar with Periodic Safety Update Reports (PSUR)

oProject manager for cross-functional teams.

oCoordinated recall activities, FDA updates, recall strategy

oSoftware Systems Mapping for user needs and user testing.

oImplementation of RoHS guidelines with traceability to DMRs

Implemented of Field Service systems for improved compliant monitoring through

oERP systems reconfiguration.

oDevice returns/repair process improvements.

oSupplier Quality – Incoming inspection yield rate improvements.

oInternal Quality – First pass yield, NCR, internal audits

oCustomer On-Time Delivery by required dates.

oCost of Poor Quality – Reducing costs of scrap, rework, and returns.

Notified Body / FDA Audits: Developed ISO 13485 QS, expanding on ISO 9001 foundation from above to meet additional requirements for medical devices.

Audit front room experience with FDA, BSI, and Canada.

Consent Decree remediation experience.

IT Data Exchange: 12 years of implementation/reconfiguration experience, launching medical device CAPA, complaint, field service, and customer service systems.

Thorough project/system launches with medical company and contract manufacturing personnel to ensure understanding of regulatory requirements and business needs.

Project planning, process development, and systems validation to ensure systems launch.

QS Onboarding of Acquisitions

Conduct meetings to develop requirements with key stakeholders.

Performed QS gap analysis.

Established executive oversight of relationship with quarterly business reviews.

Used ADKAR change management technique.

International Experience

Conducted process improvement in Italy, France, Sweden, Ireland, and Germany.

Responsible for QS in China, Italy, Japan, Australia, North America, and Brazil.

Accomplished complaint handling process improvements and configuration for global systems.

Invacare, Elyria, Ohio

Apr. 2012 to Apr. 2014

RAQA PMS Global Manager

Global Complaint Manager. Under Consent Decree brought complaint process into compliance, which required a total QS restructure.

oRestructured complaint process/system for five North America sites (10K complaints/month).

oHired/trained 50+ staff members, conducted audit training and LEAN initiatives, and passed certifications 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, certificates 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.

Stryker, Mahwah, N.J.

Oct. 2009 to Apr. 2012

Global Corporate Complaint Manager/Complaint Process Owner

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 corporate systems expenditures, global complaint training 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.

Gambro Renal Products, Lakewood, Colo.

Manager, Americas

Jul 2008 to Oct. 2009

Customer Complaint Investigation

Jun. 2006 to Jun. 2008

Coordinated/conducted quality-training 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.

CAPA Coordinator

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.

Business Experience:

QSR Certified, CAPA Certified, Complaint Certification, Medical Technologist, International Experience, Medical Device background, Class I, II and III

Windows, Excel, Power Point, Management Experience, Leadership skills

Excellent Organization and Communication Skills, Self-Motivated, Project Management

CPR Certified-Professional Rescuer, FDA, EU MDD, QSR, ISO13485, Lean, and multiple regulatory reporting regulations experience

Green Belt / Six Sigma Certified

Volunteerism

200+ hour of volunteer work in a Community Hospital

National Multiple Sclerosis Society, Race for the Cure Triathlon,

Fund raising: Aids Walk Colorado 1997-98 $1,000 raised

Memberships

American Society for Cell Biology

Regulatory Affairs Professionals (RAPS)

Association. for the Advancement of Medical Instrumentation (AAMI)

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