Professional Experience:
Teva Pharmaceuticals Ltd. (Davie, FL) 05/2019 – 05/2021
Responsibilities:
- Validation and Qualification Review
- SME for CAPA Workstream Lead
- Lead the CAPA Remediation Team for Engineering
- Creation of SOPs
- Investigations for process/equipment failures (Deviations)
Key Accomplishments:
- Completed Validations and Qualifications to allow for commercial release of product
- Brought all overdue CAPAs to a complaint state (65 CAPAs)
- Closure of 365 CAPAs
- Created Project Management Matrix to track, communicate CAPA status, and drive the CAPAs to closure
- Completed 50 investigations
Aesculap, Inc.- a B. Braun company (St. Louis, MO) 10/2018 – 07/2019
Responsibilities:
- Lead the Validation Team
- CAPA, Service, P&PC and Referb workstream lead
- CAPA Remediation SME
- Implemented new CAPA process
- Remediated CAPAs for: Quality Management System Processes, Product and Manufacturing, and Risk and Design Controls
- This included reviewing each CAPA to verify if the correct Root Cause was determined and documented correctly.
- Provide guidance and consultant on compliant process Workstreams for process improvements and complaint remediation
- Member of the CAPA Review Board
- Creating Protocols for complaints, MDR remediation, and EU Medical Device Vigilance Reporting
- Executing of Protocols for remediation of complaints, MDR remediation, and EU Medical Device Vigilance Reporting
- Creation of SOPs
- Worked with Refurb Manager to implement process work instructions and process monitoring metrics. Reviewed draft work instruction with actual practices for compliance.
Key Accomplishments:
- Validation of product packaging for shipping of devices
- Implementation of a new CAPA process
- Completion of over 269 CAPAs
- Completions of CAPA remediation
- Successful completion of the execution of protocols for complaints MDR remediation, and EU Medical Device Vigilance Reporting
Cook Medical (Bloomington, IN) 02/2016 – 10/2018
Responsibilities:
- Lead the CAPA Remediation Team
- Lead the CAPA Validation Team
- Completed Test Method Validations (TMV)
- Implement new CAPA process
- Lead Various CAPA teams for Quality Management System CAPAs, Product and Manufacturing CAPAs, and Risk and Design Controls CAPAs
- Provide guidance and consultant on various process Workstreams for production and process controls, process improvements and compliance to various standards
- Review of all CAPA phases prior to phase approval
- Creating Protocols and Execution of Protocols
- Creation of SOPs
Key Accomplishments:
- Completed Validations for Saline Solution process, combination products, and water purification systems
- Worked with receiving inspection to develop incoming inspection plans and inspection level creation (loosen inspection, tightened inspection, Dock to Stock)
- Implementation of a new CAPA process
- Closure of interim CAPA Process
- Complete review of all product label against applicable requirements
- Completion of over 100 CAPAs (team approach)
- Warning Letters lifted
- FDA audits with no repeat findings
- Completions of CAPA remediation
- Successful completion of execution of protocols
- Creation of and edits of SOPs for process compliances and improvements
Philips Medical Systems (Cleveland), Inc. 01/2012 – 02/2016
Highland Heights, OH
Senior Manager, Process/Product Quality (Interim Director) 08/2014- 02/2016
Sr. Manager, PQ is responsible for Operation Quality Assurance including Receiving Inspection, In-process quality, Quality Engineering and Product Release. The position is accountable for quality and regulatory activities supporting Operations, new product integration & product transfer and sustaining projects.
Responsibilities:
- Workstream lead (P&PC, Supplier Quality, Change Control)
- Process Validation
- Product Quality Engineering, Receiving Inspection / In-process inspection & Final Product Release.
- Review and edit Supplier Quality agreements and acceptance criteria
- Overall assurance of production/manufacturing compliance.
- All shop floor (production/manufacturing) quality including resolution of any product deviations within the factory.
- Supports the operations team and operations leadership.
- Compliance and quality coach and mentor of personnel for all assigned areas of responsibility
- Develops and administers the department's short- and long-term goals and objectives.
- Responsibility to staffing and organizing the Product Quality Team for sustainability.
- Continuous improvement activities within the department.
- Product labeling review and approval – (all product labeling: Product brochures, Device Labeling, Device Manual Labeling, etc.…)
- 510K reviewer
- Member of the CAPA Board
- Member of the Recall Team – Reviewed proposed recalls for scope and adequacy
Key Accomplishments:
- Completed process validations
- Attained third party certification of production processes, which allowed shipping of devices
- Drafted Supplier Quality Agreement and acceptance criteria for supplied materials
- Classified and certified suppliers based on criticality of materials supplied
- Increased capacity and efficiency in the receiving and receiving inspection processes
- Specifically, the ability to inspect the inflow of materials within 24 hours
- Redesigned and moved the receiving and receiving inspections areas to create an optimal flow of materials throughout the process
- Increase the quality of records produced
- Restructured of the Product Quality and Product Release teams to efficiently meet the needs of the organization
- Optimized the Nonconforming process and flow of Product/materials through the process
- Recognized as a Role model multiple times throughout my tenure at Philips
- Develop and Business Excellent Systems Team
- Completed Gaps analysis of entire QMS and established correction and corrective action plans to address the gaps
- QMS recertification and production restart
- I Lead the Product Quality remediation team to a successful QMS and Product recertification
- Closed 6 Product Quality CAPAs
- Created a compliant NCR process
- Reduced the number of NCRs by 45%
- Closed over 4000 NCRs
Senior Quality Management System Manager
(Change Management, Document Control, and Training) 01/2012 – 08/2014
Responsibilities:
- Work-Stream Lead, lead a cross functional team to improve deficiencies in Quality Processes
- Created compliant processes
- Eliminated backlogs of work
- Increased capacity and efficiency
- Change and Document Control Program Manager
- Ensure the organization is achieving and maintaining compliance to the Quality System Regulation (21 CFR 820) through the establishment, maintenance and control of the change and document control processes supporting quality system documentation.
- Review proposed changes to documents and assess the impact to the quality system (CT/NM, Imaging Systems and Philips Healthcare) including training requirements.
- Manage Change Control Board.
- Review training content to assure alignment with procedures.
- Monitor and control incoming and outgoing document changes to assure requirements are met and documents are processed in a timely manner.
- Review, approve and publish documents through software tools.
- Define and create metrics for Document Control. Monitor KPIs and respond to trends.
- Member of the Recall Review Board
Key Accomplishments:
- Work-Stream
- Created compliant processes
- Eliminated backlogs of work
- Increased capacity and efficiency
- Redesigned the Change and Document Control and Training processes
- Processed over 300 Change orders and 600 documents and the associated training deliverables
- Increased capacity and throughput
- Integral part of the Warning Letter response team
- Lead remediation activities
- Critical reviewer of proposed changes to the Quality System
- Part of the team that successfully had a FDA Warning Letter Lifted
- Service Returns and Refurb Processes
- Worked with the Service Manager to implement a quality system and processes for service returns and their refurb process.
- Successfully implemented and achieved a certification of the quality system.
Terumo Cardiovascular Systems 08/2010 – 01/2012
Ann Arbor, MI
Quality Assurance Chief (Manager Position)
Responsibilities:
- Manage, investigate, plan and implement improvements in Terumo’s quality system.
- Lead projects which require Quality Assurance (QA) team effort and/or multi-discipline team effort.
- Ensure compliance to Terumo’s quality policy, respond to customer complaints, schedule and perform audits and review/write procedures as required.
- Conducted Design reviews
- Member of the Safety Board which included the review of data to determine the need and extent of recalls.
Specific Duties:
- CAPA Management
- Provide direction, scoping, review, approval, and communicate progress to Executive Management.
- Internal Audit Program
- Schedule, train auditors, implement audit plan, and report on audits.
- Lead the CAPA Quality System Work-Streams associated with the Consent Decree
- Quality Systems
- Improve and maintain the Quality System
- Ensure and monitor that adequate training is performed and competency is maintained/achieved
- Direct reporting staff includes
- 2 Senior/Lead Engineers, 2 level II Engineers, 2 level I Engineers, 6 Consultants (CAPA Experts)
- Plan, implement and lead projects including organizing and coordinating resources (personnel, materials, time, department budget, etc.).
- Maintain and follow proper compliance and quality systems requirements.
- Communicate effectively with customers.
- Management Representative – alternate
Key Accomplishments:
- Quality Systems
- Created compliant processes for CAPA., Design Review, Internal Auditing
- CAPA
- Compliantly with my team closed over 237 CAPAs and CAPA Requests
- Other
- Worked with cross functional teams to investigate product defects
- Successfully released a new Vein Harvester – Member of the team
Jabil Inc. 08/1996 – 08/2010
Auburn Hills, MI
Contract manufacturer of an array of finished medical devices and of automotive assemblies and components
Quality Management Systems / Environmental Engineering Manager 2003 – 08/2010
In this capacity, I reported to the site Quality Systems Manager with dotted line reporting to the Corporate VP of Environmental Engineering and Quality.
Direct reports: Lead Internal Auditor, Internal audit team, Quality Systems Engineers, Quality Systems Analysts, Supplier Quality Engineering, Receiving, Receiving Inspectors, and Quality Inspection.
I was also the Management Representative for the plant.
- Managed the following:
- Process Validation, Test Method Validation, Gauge/Tool Qualification
- Quality Systems
- Supplier Quality Controls
- Managed Quality Engineering Team
- CAPA/NCRs
- Internal Auditing and Document Control in compliance with these Standards and Regulations: ISO 13485, ISO 9001, ISO/TS 16949, ISO14001, ESD S20.20 and 21 CFR Part 820.
- Change and Document Control
- Record retention/storage
- Receiving, Receiving Inspection, Quality Inspection
- All customer visits/audits and communication
As the manager of the internal and external auditing programs, which focus on ISO and QSR compliance, I am a certified auditor for ISO Standards: ISO 13485, TS 16949, ISO 14001 and ISO 9001.
As the Lead Process/Product Quality Engineer and Lead Quality Systems Engineer for the plant my duties included:
- Investigating product/process nonconformities
- Interacting directly with our customers to improve the design for manufacturability
- Process validation (IQ, OQ, PQ)
Responsibilities:
- Worked with the Process Quality Engineering Department on improvements for:
- Process Validation, Test Method Validation, Gauge/Tool Qualification
- Process Failure Mode Effect Analysis (PFMEA)
- Supplier Quality Agreements and Score Cards
- Control plans
- Process flows
- Process design (material flow, work area agronomics)
- Conformance, Compliance, Non-Compliance Reports (NCRs)
- Tooling procurement.
- Segregation of WIP, etc
Additionally, I was responsible for the management, facilitation, coordination, and execution of our site’s Environmental Management Systems (EMS). I performed all duties as the site Environmental Management Representative (EMR).
Key Accomplishments:
- No identified audit nonconformances for Process Validation, Test Method Validation, or Gauge/Tool Qualification
- I was the lead for the team which completely rewrote the Quality System. Business Systems Excellent Team (BEST team lead)
- Recognized as achieving best in class for our Quality System
- Implemented our Quality System Corporate Wide (50 sites)
- Throughout my career, I was an integral member of the teams that achieved certifications to ISO 13485, TS 16949, ISO 9001, ISO 14001, and ESD S20.20.
- Maintained all of the site’s certifications.
- Identified over a million dollars of annually saving through identifying and address improvements and nonconformities through the Internal Audit program.
- Implementation of a new Process Validation process. Complete Validation of the facility including: each production line’s equipment, labeling process, and DI and Water purification systems.
- For last few months I was a Business Unit Manager
- Responsible for all Customer communications
- Maintained Budget for Business Unit
- Resource Management
- Capacity Modeling
- Leading Cross functional teams for improvements and addressing nonconformities impacting the performance of the Business Unit
Education:
University of Michigan
Bachelor’s degree
Professional Continuing Education/Certifications:
Six Sigma Green Belt Training
Trackwise
SAP
How to Facilitate Change
Root Cause Analysis training (Tom Weaver)
KT Root Cause training – KT Root Cause trainer training
ISO 13485 / ISO 9001 RABQSA certified FDA Regulated Industries Lead Auditor
QSR (Medical) Interpretation and Implementation
Internal auditor training for FDA Regulated Industries
ISO 9001:2000 Internal auditor certification
ISO 14001: 2004 Internal auditor certification
ISO/TS 16949: Internal auditor certification
Reengineering training
Continuous Improvement
RAB approved ASNI/ISO/ASQ 9001-2000 Transition Training
Train the Trainer
Hazwoper certification
Hazardous Waste Generator Training