Frank Pucci: in Placentia, CA

Responsible for all quality control and quality engineering functions for custom injection molding organization. Work with Engineering and Manufacturing on process development, qualification and improvement including Six Sigma, 5S and Lean activities. Responsibilities also involve managing organization's Quality Management System (ISO-9001, ISO 13485 and IATF 16949 registered), cleanroom development and monitoring, as well as FDA Medical Device Manufacturer registration and obtaining UDIs for companies medical products.

Responsible for all quality function activities for custom injection molding organization. Work with Engineering and Manufacturing on process development, qualification and improvement including Six Sigma, 5S and Lean activities. Responsibilities also involve managing organization's Quality system and ISO-9001 registration.

Responsible for quality control and quality engineering activities for multi-site contract packaging, thermoforming and custom injection molding organization. Interact with customers and suppliers on product introduction, process improvement and business review activities. Responsibilities also include upgrading quality system to ISO 9001:2000 standard and maintaining FDA medical device manufacturer registration.

Responsible for qualification and on-going evaluation of supply chain for entire organization. Negotiating contracts and terms with suppliers and develop strategies for improving overall costs associated with purchased products.

Responsible for quality assurance for manufacturer of custom medical procedure packs. Managed projects aimed at cost reduction and quality improvement. Performed procedural compliance audits and environmental monitoring of facility. Statistically analyzed and reported quality trend data. Facility trainer for company quality improvement process.

Responsible for quality assurance of incoming materials for $60 million medical manufacturing facility including vendor evaluation and customer interface. Experienced in GMP compliance activities. Coordinated team transfer of operations to outside vendors and other company facilities in conjunction with facility closure. Facility trainer in statistical process control and ASQC certifications. Promoted from Supervisor, Quality Assurance of Injection Molding Department.

- Cleveland, Ohio 60 million-dollar manufacturing facility producing extruded, co-extruded and blown film for packaging industry. Quality Supervisor, December 1988 through April 1990

Manufacturer of custom silicon based polymers, emulsions and de- foamers.