Joseph (Jay) Moniz Email and Phone Number

Small business owner of the TQAG. We validate the usability and functionality of consumer electronic products, e.g., Consumer electronics (digital cameras, digital video cameras) Night Vision Scopes, Binocular Cameras, Small Household appliances, DSLR Camera Accessories.Regulatory compliance process implementation management: i.e., ISO 9001:2008, AS9003

Retired

Responsible for supporting the quality assurance department promoting product quality and quality system compliance consistent with T2 Biosystems’ company goals including the direction, planning and execution of quality improvement initiatives.Supports the establishment and maintenance of the Quality System in compliance with QSR, ISO, EN and IVDD regulations. Manages multiple programs, and interfaces with a variety of internal and external stakeholders. Prevents or eliminates defects in new or existing products by performing the following duties personally or through delegation.Duties &Responsibilities:• Coordinate and/or directly review and approve design history file (DHF), device master record (DMR) and device history record (DHR) documentation for T2Biosystem products.• Develop, review and approve verification and validation protocols for T2 Biosystems quality system elements, product design activities and manufacturing processes; execute protocols and generate reports as necessary.• Troubleshoot process problems, define root causes, coordinate implementation of corrective actions and verify corrective action effectiveness.• Develop IQ, OQ and PQ protocols for measurement, test, quality system and manufacturing equipment/software; execute protocols and generate reports as necessary.• Manage Material Review Board; assure appropriate processing of non-conforming materials and Supplier corrective actions..• Performs internal and external auditing. Supports timely completion of Audit findings. • Manage Corrective and Preventative Actions (CAPA), including timely implementation of action items.• Serve as QA representative; Manage process and product-related deviation activities; track deviations and report on trends.• Generate and present quality reports that track trends in: supplier quality, in-process test results, finished product yield, complaint trends, CAPA and audit status.

Systems Quality Engineer conducting routine and non-routine analysis of raw materials, in-process and finished formulations, compile data for documentation of test procedures and prepare reports according to Standard Operating Procedures (SOPs) in a GMP compliant environment. Additional duties include support to document control, internal audits, investigations, non-conformances. • Advise and support Manufacturing and R&D with respect to process development, changes, validations and investigations• Perform Internal Auditing to ISO-9001 requirements• Create procedures for Quality System changes and improvements• Manage quality systems corrective/preventive actions and non-conforming product as required.• Complete projects in a manner consistent with objectives.• Support the Microbiological/Sterility testing process on Incoming and In-process inspection products.• Assist in the development and implementation of Quality Assurance systems, specifications, test methods, sampling plans and related written procedures as required.• Conduct supplier audits, quality reviews and corrective actions.

Comprehensive regulatory affairs management of new/existing industrial vacuum products. Resource management for design and development of quality, environmental and reliability test plans for new products.Failure analysis investigations and continuous improvement management. Quality metrics; design, implement and report: First pass yield, AFR, DEFOA, trend analysis.ISO audit management.

As part of the Quality team responsible for ISO certifications, root cause analysis, continuous improvement projects, assisting Quality Manager with establishing, implementing and maintaining the quality management system, conduct audits, create and maintain company quality documentation such as quality manuals and procedures.

Responsible for functionality, usability, overall product quality and reliability of CE imaging products. Design and implementation of standardized and non-standardized evaluations to insure that products meet consumers' expectations. Expertise in image quality performance for digital cameras, LCD TVs and digital picture frame products.Experience in supplier/vendor approval management.

Worked for Polaroid Corporation in various capacities and increasing responsibilities in new product development and qualification activities. Was involved in program planning activities for the Systems Quality and Reliability Group. Responsible for the development and execution of test plans for Instant cameras, Digital cameras and various consumer electronics products.