Christopher Izzo Email & Phone Number

New York, United States

San Ramon, California, US

San Ramon, California, US

San Ramon, California, US

 Multi-site quality system and regulatory compliance responsibility including secondary packaging and labeling, Americas Distribution, and global functions (supply chain, customer service, packaging and labeling design); sites FDA registered / certified to ISO13485 Direct, schedule and maintain all quality assurance activities and systems in support of.

San Ramon, California, US

QA member of senior leadership team at the Americas Packaging and Distribution facility, servicing CooperVision customers in the US, Canada, and 50 countries worldwide. Management Representative for the site with responsibility for the development, implementation and maintenance of the Quality System to ensure that all products leaving the Distribution.

Management representative responsible for quality system compliance to ISO 9001, ISO 13485, TS 16949 for highly dynamic injection molding and tooling operations serving over 150 customers.Primary audit contact for Notified Body and customer audits, including response, CAPA system tracking and action plan management. Administer and conduct internal audit.

Bridgewater, NJ, US

Provide leadership to 27 global sites and corporate functions for the implementation and improvement of the Global Quality Management System; plan, implement, and improve quality policies and systems that are compliant with relevant quality standards and regulations (ISO9001, ISO13485, 21CFR820, JPAL, CMDCAS).Perform corporate quality audits in support of.

Bridgewater, NJ, US

Provide functional leadership and direction to a team of Quality Specialists and Quality Managers responsible for surgical device new product development, manufacturing, and design maintenance at 6 operational and design sites worldwide in support of Surgical business with $0.5B in revenue.Set and drive achievement of corporate quality policies.

Bridgewater, NJ, US

As Surgical Product Development Group Leader, provide design team support for surgical product development as well as corporate compliance and improvement initiatives in area of design control. As Acting Manager of the Integrated Product Development Process, drive re-engineering of the product development and design control process including extensive.

Buffalo, NY, US

Management representative responsible for quality system compliance, continual improvement, training, and transformation to the ISO 9001 and ISO 13485 standards in a lean manufacturing, process-based environment.Corporate quality contact for subsidiary in Ireland and strategic partner in Mexico. Primary audit contact for FDA, ISO, and customer audits.

Responsible for regulatory readiness and continual improvement of FDA-registered Quality System certified to ISO 9001, ISO 13485, and EN 46001 - including customer & Notified Body external audits and FDA inspections.Administration of Internal Quality Audit program and coordinator of cross-functional audit team, including training of internal auditors.

Primary quality assurance contact for injection molding area, design team member for new products and extensions of current product lines - including qualification/validation, quality assurance specifications, and product launch and manufacturing.

M.S., Materials Science & Engineering

Graduate Research, Biomaterials

Bachelor Of Science, Engineering Science W/ Biomedical Concentration