TECHNICAL SKILLS:

• Quality, Manufacturing, Industrial, and Design Engineering - Project Leadership/Change Management - Class 1, 2 & 3 Devices.
• Quality Assurance/Regulatory Affairs Management - 21CFR803 & 820, ISO13485, MDD 93/42 CE Mark, CAMCAS, Regulatory Submissions, Design Dossiers, Tech Files, Complaint Handling-MDR, Vigilance Reports, CMDR, 510K, Device & Facility Registrations, DHR/DHF, Management Review
• Quality Systems Engineering in Aerospace/Military and Medical Device/FDA regulated environments.
• Development and Author - Quality System documentation including SOP’s, Work Instructions, Process Routers, FMEA’s, Clinical Risk/Benefit Analyses, Quality Plans, Verification and Validation Protocols, Sampling Plans, PPAP’s, Engineering Change Requests, Test Procedures, IQ OQ PQ, NCR, CAPA Deviations, Material Specs, Etc.
• Factory layouts, Throughput Analysis - Line Balance, New Equipment justification, Make/Buy analysis.
• Manufacturing Automation, 6 Sigma Lean Principles, and Continuous Improvement Activities - Kaizen, 5S, Kanban and One Piece Part Flow, Etc.
• Experienced software user including ERP & DB Systems (Oracle, Trackwise, SysPro, J.D. Edwards, SAP, Agile, AMAPS), Statistical Analysis (Excel, MiniTab), and CAD/Solid Modeling (AutoCAD, SolidWorks).

PROFESSIONAL EXPERIENCE:

Confidential, Hudson, NC

Director, Quality and Regulatory Affairs - Management Rep

Responsibilities:

• Responsible for all regulatory affairs and quality assurance activities
• Responsible for project management including resources, timelines, budgets and staff.
• Responsible for reviewing and approving all labeling, including promotional material before publication and/or release.
• Responsible for supporting the company during inspections/audits and label review assessments by the FDA, notified bodies or other international regulatory bodies.
• Manage QSR/ISO 13485 Compliance: Responsible for managing the production quality, engineering quality, and systems quality staff.
• Oversees regulatory updates and improvements to QSR and ISO systems.
• Manages the performance and development of human resources in the department

Confidential,Morrisville, NC

Quality Systems Specialist - Deputy Management Rep.

Responsibilities:

• Engineer responsible for supporting QA and RA Compliance - NPD, Reg. Submissions
• QSR Compliance to ISO, FDA, EU, CAN, UL, BSI - Author & Update SOP’s accordingly
• QA/RA Rep. on Notified Body & FDA Compliance Audits, R&D projects, Production
• Manage all QA-RA related Mfg. activities - DHR, DHF, CAPA, NCR, Int. & Supplier Audits, Complaints - MDR’s, Failure Analysis, Recalls, RMA, Inspections, Calibration, Gamma Sterilization Process
• Support Company’s regulatory compliance including ISO13485, 21CFR803, 806 & 820, MDD93/42 Certifications, Registrations, Listings, Management Review

Confidential, Raleigh, NC

Quality Engineer

Responsibilities:

• Create, develop and troubleshoot mfg. methods, equipment, tools & documentation.
• Clean Room - Aseptic process validation, process methodology.
• Project management, improving processes to lower costs and increase efficiencies.

Confidential, NC

Regulatory Affairs Manager

Responsibilities:

• Promotion from Complaint Handling Specialist.
• Medical Affairs Dept. management - 8-10 Associates.
• Overall responsibility for Product Recall and Complaint Handling processes and compliance to all relevant Domestic and International regulations.

Confidential, Bradenton, Fl

Manufacturing / Industrial Engineer

Responsibilities:

• Plan and manage logistics for three major product line transfers to sister facility.
• Author & perform validation and qualification testing.
• PPAP / First and Last Article Inspections.
• Cost engineering and standards analysis on Processes and Products.

BAXTER HEALTH CARE, INC, St.; Largo, Fl

Regulatory Affairs - Product Surveillance Associate II

Responsibilities:

• Post Market Surveillance per FDA 21CFR803 & 21CFR820, MDD 93/42 CE Mark
• Evaluation, investigation, reportability, filing, summary reporting, close out of Complaints, Initiate and process Medwatch Reports for the FDA.
• Conduct internal audits, issue CAPA’s, define and report Regulatory Metrics.
• Hazard Analysis, Recall investigations, determinations and all processing actions.

Confidential, Deleon Springs, Florida

Quality Engineer, Medical Products Division

Responsibilities:

• QC - Incoming, In-Process, Final inspections, Internal & Vendor Audits.
• Process and manufacturing engineering Projects Manager.
• Transition projects from design to production, develop and author IQ’s, OQ’s and PQ’s for Manufacturing processes.
• Sustaining manufacturing and design engineering, Production support.
• New product development, Concurrent Eng. Team TQM, Production Supervision.
• Process and tooling validation, design tooling and process methodology, PFMEA.
• Process validations, Quality Plans, Manufacturing Audit Plans and Protocols, Etc.

Confidential, Elyria, Ohio / Sanford, Florida

Promotion Manufacturing Engineer - Respiratory Division

Responsibilities:

• Transition projects from design to production.
• Develop automated test methods for quality testing and improvement projects.
• Sustaining engineering, Production Supervision.
• New product development - Integrated Product Team Core Member supporting new technology and company initiatives (Standard Work, 3P, VSM, Etc.).
• Process and tooling validation, design tooling and process methodology, Capital Expenditures.

Associate Project Engineer - Respiratory Division

Responsibilities:

• Complete concept design, prototype design, build and test, preliminary and final release of Eng. Dwgs.
• Overall responsibility for project timing and successful product completion.
• Provide engineering leadership on project through final release of drawings and production.

Regulatory Compliance Specialist - Corporate Regulatory Affairs Dept.

Responsibilities:

• Compliance to 21CFR802,806, 820 Responsible for Complaint Handling/Quality Reporting Systems, Reporting MDR incidents to FDA, Recall Management.
• Database Creation, Upgrades, Network management.
• Provide direction to Corp. Test Lab for complaint investigations/product evaluations
• Review Legal Cases and work closely with Legal Staff, Safety Committee Agenda
• Conduct new employee orientation and training on MDR/GMP/CFR Regulations.

Senior Documentation Specialist

Responsibilities:

• Design and develop OEM Parts Catalogs, Desktop publishing.
• Implement pricing strategies; Customer Service sales support; Review all Engineering Changes