Craig Lynch Email & Phone Number

San Francisco, Ca, Us

Mountain View, Ca, Us

• Support new product development in ensuring compliance with Medical Device Quality System• Lead Risk Management activities including Failure Mode and Effects Analysis• Lead the improvement of the Risk Management system• Track and manage Quality Improvement projects• Manage and Support Supplier Qualification• Communicate Product Quality issues throughout the organization: Operations, Quality, and Engineering… Engineering to Executive Level

San Francisco, California, Us

• Develop and implement product design and development plan• Develop and implement Quality controls inside of product design• Prepare deliverables and schedule for all individual projects• Prepare Quality metrics, deliverables, and schedules for all projects• Communicate requirements, deliverables and timeline to all stakeholders and senior leadership on a regular basis• Participate in the Core team meetings as the representative for Quality• Participate in the Core team meetings as a Champion of Quality• Identify and evaluate resources for all programs• Prepare and maintain program budget• Manage and communicate risks for all programs (to executive leadership)• Organize and chair Quality Core team meetings and program review• Identify processes and procedures for improvement• Manage timelines for deliverables, estimation and prioritization

San Francisco, California, Us

• Support new product development in ensuring compliance with Medical Device Quality System• Lead Risk Management activities including Failure Mode and Effects Analysis• Lead the improvement of the Risk Management system• Track and manage Quality Improvement projects• Manage and Support Supplier Qualification• Communicate Product Quality issues throughout the organization: Operations, Quality, and Engineering… Engineering to Executive Level

Franklin, Tennessee, Us

● Managed and lead the Quality team● Measured and managed performance of the product team.● Planned, coordinated, and directed Quality program designed to ensure quality control and quality assurance of the production of devices consistent with established standards● Applied statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.● Ensured product compliance through inspection and auditing activities● Oversaw CAPA system to ensure compliant application of the Corrective and preventive Action program.● Actively sought continual systemic improvement for CAPA, MRB and complaint reduction.● Directly responsible for performing or coordinating calibration, testing environmental monitoring, and sterility assurance.● Formulated and maintained quality objectives in alignment with corporate policies and goals.● Performed quality engineering reviews of design documentation for compliance with stated requirements.● Engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products.● Designed and implemented Quality training programs to key personnel in conjunction with managers.● Investigated customer complaints as they relate to the Quality Management System.

Los Angeles, Ca, Us

● Oversaw compliance of quality management system (QMS)● Fulfilled the role of Management Representative per QMS● Coordinated quality metrics reporting for management review● Maintained facility QMS certificates, registrations, licenses and device listings● Compiled and maintained DMR (Device Master Records) and technical files;organizing required documentation such as drawing, inspection reports,labeling, bill of material, SWIS, and work ticket etc.● Prepared and submitted adverse event reports to FDA, Canada, andCompetent Authorities● Managed the Documents Control and Change Control process● Managed complaints process● Repair Control Sheet review● Managed quality audits● Managed product removals and corrections● Maintained calibration schedule and facilitated calibration● Supported design development activities● Assisted in product registrations and licensing per regulatory requirements● Participated in nonconforming materials review program; member of materialreview board● Supported supplier selection process● Supported process validation activities● Handled tech support● Managed DHR approvals● Managed organizational Kaizen Teian program

Los Angeles, Ca, Us

●Helped students at The USC School for Early Childhood Education in learning daily lesson objectives.●Assisted teachers in supervision and management of up to 18 children, ages 3-5.

Los Angeles, Ca, Us

●Organized, formatted and uploaded entries into the Digital Folklore Archives at the University of Southern California●Meticulously maintained database utilizing technical proficiency.

Washington, Dc, Us

●Coordinated and scheduled all preventative and corrective maintenance actions for an inventory of electro-optical instruments and systems, which included over $5,000,000 worth of advanced equipment.●Performed electro-optical maintenance and repair to ground ordnance laser and night vision devices, small missiles systems, and other fire control equipment.●Performed mechanical, mechanical-optical and electrical repairs to include inspecting, troubleshooting and adjusting fire control instruments and systems.●Completed basic shop administrative forms and records using technical publications. ●Trained, supervised, and performed various duties and tasks incident to the management of an electro-optical ordnance repair facility.●Managed several operations personnel in a fast-paced and stressful environment.●Experienced in maintenance administrative procedures, repair analysis, technical inspection procedures, repair procedures, testing of ordnance equipment, and quality control methodology.●Received a Certificate of Commendation for professional achievement.