PROFILE:

Quality Systems Engineer with over 15 years experience delivering notable cost saving results, operational improvements, and productivity increases in Start - ups and Fortune 500 medical device/ pharmaceutical companies. My primary focus is Process Improvement and Design Control. Extensive experience in Biotechnology and Quality Assurance 510k launch Class I, II and III devices. Major contributions in Federal government and private Research and Development. Diversified range of statistical data interpretation and Computer System Validation (CSV). Team motivator.

CORE COMPENTENCIES:

Administrative: ISO 13485/ 14971 / 9001 / 21 CFR 820/ 211/ 11 ISPE GAMP 5 FDA audits EU Directives ISO 8, ISO 7, ISO 5 Cleanrooms Author of procedures grant writer published in medical journals.

Technical: Root Cause Analysis 8D Methodology Active Pharmaceutical Ingredient Analysis Organic Compounds Biosafety Lab III Certified QC Inspections Mold Qualifications Device Validation IQ/ OQ/ PQ / IMV/ TMV FMEA CAPA cGMP Keyence Systems, Optical Comparators CMM Smart Scopes

Software: SAP, Mini Tab, SAS, Solid - Works, Microsoft Office, SharePoint

PROFESSIONAL EXPERIENCE:

Confidential, Peachtree City, GA

Quality Systems Engineer/ Program Manager

Responsibilities:

• Responsible for the advanced technical support of the Quality Control/ Quality Assurance department within the plastics injection molding and assembly production facility.
• Execute validations for over 55 injection molding machines. Program Manager for Peachtree City site Quality Systems.
• Conduct statistical analysis in the form of capability studies and control charts to evaluate processes.
• Provide validation input for DOE, FAT, SAT, DQ, IQ, OQ, PQ on internal equipment and machines.
• Supervisor of 18 Quality Control Technicians (4 shifts)
• Perform Environmental Monitoring and Hygiene activities for all ISO 8 Cleanrooms
• Site Super User for SAP-QIM (Quality Issue Management) program for customer complaints/ RMAs
• Manage the Calibration program for all calibrated equipment for both Production and R&D

Confidential, Minnetonka, MN

Senior Validation Engineer/ Quality Engineer

Responsibilities:

• Authored and oversaw Test Method Validation procedures for cardiovascular and ablation technology device manufacturing.
• I evaluated process to determine potential inconsistences to design outputs and technical issues for Quality improvements.
• Review medical device manufacturing rejects for evaluation to Material Review Board (MRB).
• Developed Inspection Methods and Test Method Validations (IMV/ TMV) Protocols, Executions and Reports
• Performed the execution of Performance Qualification (PQ), Product Performance Qualification (PPQ)
• Lead cross - functional team in the transfer of equipment and process to new manufacturing location
• Coordinated inspection activities for QA Bench/ Techs for manufacturing, validations, and tool qualifications
• Investigation of non-conformances, complaints, and CAPA resolutions

Confidential, Duluth, GA

Medical Safety Expert (Consultant)

Responsibilities:

• Processed technical and medical complaints related to contact lens manufacturing.
• Evaluated complaints to determine potential severity/ harm to patient and technical issues for R&D improvements.
• Reviewed medical complaints for (MDR) evaluation with FDA and Canadian Health Authorities.
• Coordinated and participated in material review activities to determine nonconforming product dispositions
• Met regularly with on - site Optometrist for medical case reviews.
• Revised quality procedures and protocols to reflect current GMP methodology and site specific processes.
• Communicated with equipment vendors and internal process owners for impact assessment of system changes.
• Developed validation strategies, protocols, and over-saw execution of equipment qualifications used in pilot
• Research and Development of contact lens produced in Clean Room Laboratory.
• Lead Pilot Lab technical meetings involving implementation strategy of new R&D contact lens process.
• Wrote Validation Master Plans, test scripts for computerized systems & programmable logic controllers (PLC’s).

Confidential, Jacksonville, FL

Senior Process Validation Engineer (Consultant)

Responsibilities:

• Developed Process Validation plans for current and next generation Equipment (Computerized/ Automated Production Process).
• Developed Test Method Validations (TMV)/ qualification strategies for Computerized/ Automated System.
• Performed Root Cause/ CAPA audits via Global Quality Engineering Group, Regulatory Affairs, and Metrology.
• Lead the C.O.T.S. Validation program and transferring of R&D plastics measurement technology to production.

Confidential, Research Triangle Park, NC

Senior Quality Engineer

Responsibilities:

• Implemented Corporate Design Control policies and procedures resulting in comprehensive adherence to Approved specifications reducing rejection rates by 30%.
• Conducted peer review of QMS and QSR/ CFR part 820.
• Provided QA input for Material Review, First Article Inspections and Supplier feedback on Nonconformance reconciliation.
• Organized DHF and DMR system for more efficient retrieval of device history records.
• Guided Draftsman and Engineers in updating over 4,000 Inspection and Supplier prints.
• Worked with Complaints Department investigating and reducing the number of unresolved customer complaints from 400 to 100, emphasizing risk priorities.

Confidential, Covington, GA

Quality Engineer (Consultant)

Responsibilities:

• Collaborated with Senior Quality Management team closing out discontinued product line.
• Performed Test Method Verification for bulking agent needles and catheters, (DOE) Designed Experiment.
• Wrote Incoming Inspection Protocols including AQL Sampling for QC Laboratory.
• Conducted Internal Quality Audits, Inspections and review of Device/ Design History files.

Confidential, Clarkston, GA

Quality Control Specialist

Responsibilities:

• Analyzed clotting (Active Pharmaceutical Ingredient) data expelled from Blood Coagulation Testing instrumentation.
• Performed statistical analyses on performance data per Sidney, Australia manufacturing transfer.
• Performed IQ, OQ/ PQ and on Lyophilizers, Incubators, Packaging Sealers, and Process (DOE).
• Investigated outbreaks of acute gastroenteritis in nursing homes, restaurants, and cruise ships.
• Collaborated with international team to design research methodology, data management, specimen analysis, and implications of diagnostic results.
• Performed PCR, RNA extraction analysis on incoming patient specimens.
• Generated data used in vaccine (Bovine geno/ sero plasma) research of exposure to Norovirus.
• Consulted with epidemiologist and clinical physicians to establish improved methods of prevention, diagnosis and sanitizing high probability areas of commercial cruise ships. Positive Confirmation of my personal hands on lab results and other logistics would determine docking of multi-million dollar vessels for quarantine.