SUMMARY:

• Quality Systems Engineer wif 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 d Confidential interpretation and Computer System Validation (CSV). Team motivator.

TECHNICAL SKILLS:

Administrative: ISO 13485/ 1 01 / 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:

• Conduct statistical analysis in teh 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 teh Calibration program for all calibrated equipment for both Production and R&D

Confidential, Minnetonka, MN

Senior Validation Engineer/ Quality Engineer

Responsibilities:

• Developed Inspection Methods and Test Method Validations (IMV/ TMV) Protocols, Executions and Reports
• Performed teh execution of Performance Qualification (PQ), Product Performance Qualification (PPQ)
• Lead cross-functional team in teh 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

Responsibilities:

• Processed technical and medical complaints related to contact lens manufacturing. Evaluated complaints to determine potential severity/ harm to Confidential t and technical issues improvements.
• Reviewed medical complaints for (MDR) evaluation wif FDA and Canadia Health Authorities.
• Coordinated and participated in material review activities to determine nonconforming product dispositions
• Met regularly wif on-site Optometrist for medical case reviews.
• Revised quality procedures and protocols to reflect current GMP methodology and site specific processes.
• Communicated wif 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

Confidential, Jacksonville, FL

Senior Process Validation Engineer

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 teh 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:

• 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 wif Complaints Department investigating and reducing teh number of unresolved customer complaints from, emphasizing risk priorities.

Confidential, Covington, GA

Quality Engineer

Responsibilities:

• 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) d Confidential expelled from Blood Coagulation Testing instrumentation.
• Performed statistical analyses on performance d Confidential per Sidney, Australia manufacturing transfer.
• Performed IQ, OQ/ PQ and on Lyophilizers, Incubators, Packaging Sealers, and Process (DOE).