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 corporate quality system and global standards and regulations - including management review, CAPA, customer complaints, change management, validation, product release, internal and supplier audit program Hire, supervise, develop and evaluate personnel to ensure success and achievement of quality system objectives

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 Center meet customer quality expectations, internal quality standards, Food and Drug Administration (FDA) Quality System Regulations and international regulatory requirements. As part of the global RA/QA and Operations team, supports and leads quality initiatives for global programs.

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 program for all key processes including scheduling, performance, and reporting.Supervise and develop a department of 30 staff members including engineers, lab technicians, inspectors, and administrative personnel.

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 the compliance schedule, across all business segments and locations, including reporting results to sites, functions, and top management; scoring and issuance of CAPA activities, assisting with development of audit schedule and interface with other audit team members.Lead the quality systems, training, and document management segments of the Global Quality Compliance group, lead and staff quality system initiatives and improvement efforts; act as subject matter expert in support of audits and inspections.

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, procedures, and objectives including compliance to US and global regulations and standards.Improve and implement global processes for design control, risk management, change management.Represent the corporation in regulatory interactions including providing guidance to suppliers and partners.

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 procedural revisions, training content development and delivery in 8 months.

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, including response, CAPA system tracking and action plan management.Oversee identification, mapping, and management of key processes including company-wide training of process owners, establishment of metrics, and management review of performance.

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, review and approval of audit reports, and follow through on resulting CAPA.Responsible for review and maintenance of multiple 510(k) files and CE Mark technical files - including creation, submission, and approval of new 510(k) technical files.

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