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Quality Assurance

Arlington, Texas, 76063, United States
March 08, 2012
Contact Info:

Jonathan Clark
Mansfield, TX *****
214-***-**** -
● Quality Manager, Certified Quality Auditor and Certified Quality Engineer with skills in product development, auditing to US and EU standards, and CE technical file preparation
● Policy, procedure, and work instruction preparation for all aspects of the quality system
● Strong focus on product development, release and postproduction surveillance, quality systems and EU registrations
● Experienced in identifying issues and solutions through building relationships among divergent groups facilitating creative and timely successes throughout the supply chain

● Multiple product launches (Excell 22, Advia 70, Hemavet 950, Axim 3000 chemistry reagents, DiscoVisc, ProVisc IBC, Outlook 151599 MP software, Space DLE 4.0 service disk)
● Defense of Drew Scientific, Alcon Laboratories and Delta Group Electronics during several FDA and ISO audits
● Implementation of ISO 13485 quality system conversion from ISO 9001:1994
● Redesign of complaint system and change notice system
● Implementation of ISO 9001:1994 in the Quality Control department including statistical process control and product release
● Initiation and startup of an Incoming Inspection department with sampling plans and statistics
● Managed the transfer of HemaVet hematology blood analyzer product from another manufacturing site

B. Braun Medical 2/2011 – 2/2012
(Infusion Pump Manufacturer)
Quality Assurance Supervisor
● Managed three technicians and two software quality engineers as the team wrote and performed validation and verification protocols for IV pump software and hardware release
● Managed three documentation clerks in all document control activities using both automated and manual systems
● Performed project management for the release of software, including GMP compliance, risk analysis, project plan, design phase review meetings, verification and validation plans and protocols, release through change orders, and managing the design transfer plan
● Managed configuration control of pre-release design outputs be it software or hardware
● Modified procedures and work instructions to improve compliance, close corrective actions, and lean processes
● Initiated validation master plan

Delta Group Electronics 5/2009 – 2/2011
(Electronics and Cable Manufacturer)
Quality Manager
● Converted existing ISO 9001 quality system documentation to be compliant with corporate procedural requirements
● Collected and defined metrics from the management information system and manual input spreadsheets
● Managed calibration and maintenance activities, CAPA, AS 9100 internal audits, trained internal auditors, served as management representative, designed process validations (IQ, OQ, PQ), and managed the quality control department
● Created the site PFEMA to analyze and mitigate process risks

Verify, Inc 4/2010
(Contract Quality Services Provider)
Contract ISO 13485 Lead Auditor
● Performed full quality system assessment to ISO 13485 while educating primary contacts on the requirements and approaches to working in the medical device arena

Alcon Laboratories 4/2006 – 4/2009
(Manufacturer of eye solutions, drugs and devices)
Quality Engineer II – Systems (Product Development/Registrations)
● Represented quality assurance and supported OEM and branded surgical devices marketed globally including: Custom Paks, Cellugel, DisCoVisc, ProVisc, Viscoat, DuoVisc, Surgical Drapes, ISPAN Gases, Perfluoron, Silikon Oil, Optemp, SofGuard Eye shields, and Gelaser Gel through a detailed understanding of biopharmaceutical process, including manufacturing, purification, critical system utilities and supply chain
● Managed Risk Management Reports and Post Production Risk Reviews
● Preparation of EU Technical File documentation, defense of the CE Technical Files for TUV audits, design control documentation; and advising research and development personnel of quality requirements for design control, product launch, and product support. Reviewed validation reports for all aspects of the product for compliance to applicable EN, ISO, cGLP, and cGMP standards and worked with appropriate functions to resolve discrepancies
● Prepared design history file indexes (design control) and Design input/output verification summaries.

Abbott Diagnostic Division (Contract Position) 9/2005 – 4/2006
(Clinical Chemistry Reagent Design)
Documentation Specialist Contractor (Product Development)
● Prepared incoming inspection, design transfer, and import/export documentation
● Advised research and development personnel of design control and quality requirements for the Axim 3000 high speed chemistry reagents.
● Prepared and participated in team meetings for design stage gate controls.

Drew Scientific, Inc. 8/2000 – 8/2005
(Manufacturer of Blood Analyzers)
Quality Assurance / Regulatory Manager 1/2003 – 8/2005
● Installed, maintained, and defended company’s quality system including ISO 13485: 1996 certification and compliance with GMP, FDA QSR 820, EU IVDD and EC Directives.
● Initiated and monitored corrective actions, change orders, and procedure changes to implementation.
● Reviewed and approved verification and validation reports including software validations and IQ, OQ, and PQs.
● Generated supplier surveys and audited suppliers for approval both through surveys and on site audits.
● Obtained licensure through the AgMed Program for the sale of medical devices to Iran and certificates to foreign governments from the US government
● Created certificates of origin, quality and EC compliance and controlled labeling to IVD requirements
● Oversaw the supervision of calibration program and Quality Control and created the Incoming Inspection department.
Quality Control Manager 8/2000 – 1/2003
● Maintained the quality of hematology instruments by overseeing the testing of production units at an end user level, creating testing criteria from given design specifications
● Designed experiments to examine specific problems or to proactively prevent them using statistical analysis methodologies
● Successfully installed and maintained the quality system in the QC department and performing companywide audits for ISO 9001:1994 certification and compliance with FDA QSR 820

Parkland Memorial Hospital 9/1999 - 8/2000
Blood Bank Medical Technologist

University Medical Center 8/1996 - 9/1999
Blood Bank Medical Technologist 4/1999 - 9/1999
Clinical Laboratory Assistant 8/1996 - 4/1999

Master of Science in Microbiology (Immunology)
Thesis “The Effect of Cocaine on Murine Peritoneal Macrophages”, Texas Tech University Lubbock, TX 5/1995
Bachelor of Science in Microbiology, Texas Tech University Lubbock, TX 12/1991

American Society for Quality, Certified Quality Auditor (CQA)
American Society for Quality, Certified Quality Engineer (CQE)
American Society for Clinical Pathology (Blood Banking) ASCP (BB)

Microsoft Word, Excel, PowerPoint, Access, Visio, Documentum, Adobe Photoshop, Acrobat Pro, Livelink documentation suite, SAP, and DBA
Dashboards, Pareto charts, statistical analysis, control charts, histograms, interrelationship digraphs, Poke Yoke error proofing, root cause analysis (5 why’s, fishbone and affinity diagram), DMAIC (Define, Measure, Analyze, Improve, and Control Process), value stream mapping, visual management, standardized work, process flow diagrams, work flow diagrams, VA/NVA ratio