Quality Manager

George J. Anello

***** ******* ******

Germantown, MD 20874

Cell 240-***-****

******.******@*****.***

OBJECTIVE

Motivated and results oriented Quality Manager with hands on experience in Quality Assurance/Engineering seeking challenging position to employ skills and experience it the area of, Medical Device/Biomedical Manufacturing, Injection Molding, Product Design, Process & Equipment Validation, Training, Statistical Process Control, Continuous Improvement, Project Management, Total Quality Management, ISO9001-2008, ISO 13485, AS9001, FDA- QSRs, GMPs, GLPs, & Six-Sigma.

SUMMARY OF QUALIFACTIONS

As a Quality Assurance Manager and “Troubleshooter” I have turned around operations by providing extensive experience encompassing the following relevant areas:

• Developed, implemented and managed the following quality systems: Food and Drug Administration (FDA) Quality System Requirements (QSR), ISO9001, ISO13485, and American Association of Tissue Bank (AATB)

• Developed improvement programs such as: Teaming for Excellence (supplier quality), Continual Improvement Programs and Total Customer Satisfaction

• In-Depth Management experience in the Medical Device Manufacturing, Biomedical - In-vitro Diagnostic Manufacturing, Rugged Integrated COTS Information Technology (IT) solutions for military and industrial applications, Custom Injection Molding and Electronic Printed Circuit Board Manufacturing

• Successful hands-on daily management of both professional and production employees and schedules

• Extensive audit experience with FDA Investigators and ISO9001/ISO13485 Registrars

PROFESSIONAL EXPERIENCE

November 2008 – December 2011 QIAGEN Inc., Gaithersburg, MD

Manufacturer of Biotechnology Systems & Products, 3800 employees, 1 Billion in Revenue

As the Manager, Product Quality my primary duties are promoting quality assurance throughout the organization to include management systems such as ISO 13485, FDA QSRs/GMPs, philosophies such as Total Quality Management, and methodologies such as Continuous Improvement. Setting up and maintaining controls and documentation procedures. Supporting business and manufacturing initiatives in order to increase manufacturing capacity. Interacting with regulatory authorities related to quality and compliance policies, guidelines, and systems. Leading the development and implementation of continuous improvement (i.e. lean, six sigma) initiatives with closed loop verification that these efforts meet or exceed financial goals. Performing a range of leadership roles on process improvement projects, including informal mentor, technical advisor, champion, and team leader. Reviewing all pre and post IQ, OQ & PQ Protocols Working with, the Director of Quality and stakeholders to enhance the deployment of quality thinking, methods and tools throughout QIAGEN. Spearheading quality training, including curriculum development and certification. Supporting the validations of all equipment and process that affect both R&D and Manufacturing.

July 2005 – June 2008 Crescent Industries, Inc., New Freedom, PA

Custom Injection Molding and Tool Making Company, 145 employees, 15 Million in Revenue

As the Quality Assurance Manager my primary duties were to maintain a high understanding of customer quality requirements by frequent communication with customers. Interpret and communicate quality requirements and render product clearance decisions to employees based on these customer requirements. Lead the implementation of statistical techniques for improving the quality of products, processes, and services. Provide leadership, team-building skills, training and coaching associated with the implementation of the ISO 9001-2000 Quality Management System (Quality System Management Representative). Assure that processes needed for the quality management system, and its applicable certifications, are established, implemented and maintained. Report to top management on the performance of the quality management system and any needed improvement required. Create and maintain quality plans, work instructions and procedures in conjunction with customer requirements and specifications. Actively participates in problem investigations and solutions using disciplined problem solving methodology (8-D, FMEA, Cause & Effects etc.). Maintain active records of customer complaints and corrective actions. Maintain incoming inspection plan for raw material and components used in manufacturing. Identify needs, then conducts or coordinates training of employees in new quality techniques. Maintain departmental budget. Participate in the annual strategic planning of the company. Provide applicable quality engineering support to the Quality and Production departments by performing/facilitating Quality Engineering techniques such as Process Flow Mapping, Process Capability Analysis (CpK), Gauge R&R, First Article Inspections, Pareto Analysis, Control Plans, APQP/PPQP, FMEA, Statistical Acceptance Sampling, Root Cause Analysis.

February 2004 – July 2005 Science Applications International Corporation (SAIC), Sterling, VA

Research and Engineering Company, 45,000 employees world wide, 6.7 Billion in Revenue

As the Division Quality Assurance Manager for the Tactical Information Systems Operation (TISO) (part of SAIC's Naval and Maritime Solutions (NAMS) Business Unit) my primary duties were to perform Quality Assurance/Quality Control functions in accordance with specified Quality Management System (QMS) criteria, stated procedural and technical requirements; provide technical and quality support and guidance to less experienced Quality Control personnel; prepare quality plans, evaluate and report quality metrics; lead the evaluation of non-conformances issues and proposed resolutions; perform internal audits, and qualify suppliers/sub-contractors, provide high-level support for multiple projects and interface directly with employees, suppliers and customers on computer off the shelf (COTS) hardware integration projects for government and commercially funded programs. Participate in strategic-level program planning with government sponsor and other contractor/vendor leads. Responsible for developing and managing the CM/Documentation process. Establish key metrics techniques, monitor project progress, and report results on a regular basis. Act as change agent and focal point for identification and resolution of process, risk, and quality related issues within the operation. Serve as focal point for identifying process improvement and training needs for employees of three divisions. Serve as the ISO Quality Management Representative and the Safety coordinator.

January 2002 – January 2004 American Red Cross, Washington D.C.

Blood, Plasma & Tissue Procurement and Distribution, 3200 employees nation wide, 645 Million in Sales

As the Sr. Systems Design Engineer my primary duties were to design, develop, deploy monitor, and support critical cross-functional systems for all ARC regions, National Testing Laboratories, and Biomedical Services Headquarters. National cross-functional systems include, but are not limited to: labeling control system, corrective and preventive action (CAPA) system, and document management system. Ensure optimization of compliance-critical systems identified by the ARCBS Compliance Improvement Program. Identify and document requirements to support new systems, or system enhancements, and ensures system deliverables are produced in conformance with the requirements. Integrate the use of best practices by benchmarking critical systems. Maintain consistency among system requirements. Analyzes and provide recommendations pertaining to system optimization and enhancements to continuously improve performance, increase efficiency, and reduce costs. Convene appropriate groups of BHQ and field staff, and, as appropriate, external representatives, to assist in developing effective cross-functional systems for the organization.

May 1999 – September 2001 Thermo Electron, Biosciences Division, Waltham, Massachusetts

Manufacturer of Biotechnology Systems & Products, 1100 employees in 8 countries, 150 Million in Sales

As the Director of Quality & Regulatory Affairs, my primary duties were to manage the quality and regulatory departments in seven countries. Prepared and submitted PMAs & 510ks. Coordinate the implementation of policies and procedures company-wide to meet all FDA, IVDD & MDD requirements. Work with department heads to establish and apply policies and procedures in accordance to local national and International regulatory requirements. Represent the organization to customers, partners, competitors and other elements with the company. Maintain and continuously improve a Quality System assuring the delivery of services, which meet or exceed customer expectations on time, every-time. Ensure the company is in conformance with all related regulatory requirements. Ensure procedures are in place, which guarantee that all customer complaints are completely resolved to the customer’s satisfaction in a timely manner. Reviewed, investigated and responded to all customer complaints in a timely and professional manner. Troubleshooting and solving quality problems for the entire organization by use of engineering tools such as FMEA, Design of Experiment, and Six Sigma. Incorporating quality concepts and human factor techniques in the design of organizational operations. Creating and managing supplier control systems. Developing and analyzing statistical process control charts. Performing quality cost analysis. Performing reliability maintainability and safety systems reviews. Performed internal and external quality system audits. Served as Quality Management Representative for the entire Biosciences division. Facilitated audits performed by the registers. Presented quality metrics to management staff on a monthly basis. Facilities semiannually Quality management meetings at all facilities.

EDUCATION/TRAINING

Lexington High School, Lexington Virginia

Abraham Baldwin Agricultural College – Regional Police Academy

Alabama Industrial Development Training - ISO 9000 Internal Auditor Training

Perry Johnson, Inc. – Auditor/Lead Auditor of Quality Systems ISO 9000

ASQ – Geometric Dimensioning & Tolerance (Training)

ASQ – Certified Manager of Quality/Organizational Excellence (Training)

ASQ – Certified Quality Engineer (Training)

Kempner – Tregoe Problem Solving & Decision Making (Training)

Six Sigma – Green Belt (Motorola University) (Training)

PROFFESSIONAL AFFILIATIONS

Regulatory Affairs Professional Society (RAPS)

American Society of Quality (ASQ) – Senior Member

American Association of Tissue Banks (AATB)

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