• Reviews and approves technical documentation including pre-qualification documentation, protocols, reports, drawings, and risk assessments on behalf of QA• Assists with investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues. Support CAPAs as necessary.• Ensures compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices.• Identifies and implements initiatives that improve customer facing quality, reliability, or cost reduction.• Develops, modifies, applies, and maintains quality evaluation and control systems/protocols. • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.• Consult risk-based decision making for transfer/qualification/validation activities to ensure compliance with industry requirements (cGMP, ISO 13485, 9001, and 21 CFR Part 11.)• Conducts quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks.• Ensures that technology transfer and other technical projects are successfully executed, fully documented and compliant with all corporate and regulatory requirements.• Supports the execution of pre-qualification and routine supplier audits and assessments of their processes in adherence to ISO 9001 and ISO 13485 to drive qualification of suppliers related to tech transfer projects.Project Involvement: • Unity Vision System• ISPAN Gas• Blephex

• Provided guidance on issues in line, incoming inspection, and with overall quality system. • Ensured manufacturing processes remain in a validated state and yields products that adhere to all specifications, requirements, and controls• Ensured continual improvement of site practices by applying regulatory and industry benchmark practices at site• Provided Quality Engineering support and guidance to production areas and review and approve proposed product, process, and document changes. • Supported product transfers and validations through data collection, review and approvals of protocols and reports. • Ensured there are adequate product and process controls in place for identified critical or major quality attributes and process parameters within production area. • Investigated and provide input on non-conformance events (NC) and Corrective Actions and Preventive Actions (CAPA) while providing guidance and approval. • Evaluated production processes and systems for conformance to local, global and industry standards and requirements. • Ensured that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.Program Involvement: • SAP Super User• LenSx Laser System• ORA System• Constellation Vision System• LuxOR Microscope

• Assisted with the development and implementation of quality systems and approaches within the programs and functions and develops quality plans that meet relevant standards and support proposals, contracts and customer expectations. • Investigated non-conformances to determine root probable cause and assign corrective action. • Read and interpreted engineering drawings and models of a simple to complex nature including related specifications and process documents. • Familiarity with ISO 9001 & AS9100 Quality System standards and NADCAP requirements. • Audited and measured the success of improvement efforts and ensures adherence to contract requirements and Company quality standards. • Understood the application and use of all types of precision measuring instruments used in mechanical inspection, including interpretations of geometrical and positional tolerance requirements. Other Duties • Implement customer contract quality requirements• Assures compliance to ISO 9001/AS9100• Interface with customers for all aspects of Quality• Establish inspection requirements and procedures• Resolve problems throughout the manufacturing and QA process• Maintains personnel training and certifications records• Perform supplier qualification and performance assessments• Maintain and administer the MRB system• Maintains the Internal Audit program• Perform inspections as required• Supports and participates in Internal/Supplier/Customer audits and acts as a direct representative of the company.Program Involvement:• Lockheed Martin F-35 Joint Strike Fighter Canopy• Embraer Legacy Passenger Cabin Windows

Provided customers with the best solutions in choosing the best products or resolving technical issues.Collaborated with corporate and field members in developing tools and programs.Maintains extensive and expert level product knowledge in all Microsoft products.Coordinated training programs for community leaders and educated guests about Microsoft Office.

Assisted to push project on Salton Sea Restoration.Provided intellect on environmental issue and methods to contain the salinity of the sea.Collaborated with the Deputy Director of the Economic Development Agency to create proposal about projected GeoTube marine structures.Provided methods on Dust Mitigation projects on Owens Lake.