Dave Netzley Email & Phone Number

Boston, MA, US

Responsible for all aspects of QA/QC. Sanvita is a startup medical device company. I am building and implementing a GMP/ISO 13485 compliant QMS as well as managing the VMP for the device and the buildout of the new manufacturing floor including an ISO Class 7 cleanroom.

Newton, MA, US

Lumicell is a combination product startup with a drug, capital equipment, and a sterile single use disposable. Developing the QMS to satisfy both drug and device quality system requirements. PMA submission with the CMC from an NDA.Responsible for the QMS, supplier mgt. device and pharma, process validation review, doc control, training mgt., QA for new.

MA, 01824, US

Aliso Viejo, CA, US

Quality Assurance support for new product development, verification, validation, and risk management. Quality support for production process validation, NCMR, and supplier development.

Danvers, MA, US

Managed the QMS and Doc Control. Responsible for all third part audits, FDA, Registrar, safety certification. and microbiologic. QA on new product development team. In-house SME on design control and risk management.

Responsible for the creation, implementation, and maintenenace of the quality system in compliance with FDA, ISO 13485 (CE) and CMDCAS.

Acton, Massachusetts, US

Responsible for complaints management, Quality system development and ISO/FDA audits. Worked on sterilization validation, data acquisition systems for product quality trending, and production support.

Danvers, MA, US