Don Griego Email & Phone Number

San Diego

Actively Support ALRE, Missile Defense, Nuclear, Satellite, LAS, and IRAD Programs Quality Requirements in an ISO 9001 Quality Management System.

Carlsbad

Managed an IS0 9001 Quality Management System supporting the manufacturer of sub-micron accuracy/repeatability programmable electronic actuators for commercial applications. •Supervised Inspection group; investigated nonconforming material issues and customer complaints to determine root cause, develop and verify effective corrective and preventive (CAPA) actions, eliminating recurrence and reducing costs.•Reviewed and approved Purchase Requisitions, Production Work Orders, and Manufacturing Procedures defining Quality Requirements or initiating Inspection Plans to ensure compliance to requirements.•Performed Engineering Design Review and approved Drawings for conformance to Geometric Dimensioning and Tolerancing per ANSI Y14.5. •Managed Calibration of precision measuring equipment initiating procedures and work instructions, •Worked with Engineering and Procurement to qualify, develop and manage suppliers.

San Diego

Ensured supply chain, production and test compliance for Satellite Bus Structures, Reflectors, Tower Assy’s and Solar Array Programs to customer and AS9100C requirements.•Reviewed and approved Production Work Orders, Quality Plans, Manufacturing Procedures and Engineering Drawings, for manufacturability, inspectability and conformance to GDT per ANSI Y14.5.•Performed internal, supplier audits and assisted in Regulatory and Customer Audits to AS9100 & ISO 9001 Quality Systems requirements.•Investigated nonconforming material issues and customer complaints to determine root cause, develop and verify effective corrective and preventive (CAPA) actions eliminating recurrence and reducing costs.•Researched, assembled and submitted End Item Data Packs to satisfy Quality documentation requirements for product shipment.

San Diego

Ensured compliance of supply chain raw material and components for Class I – Class III Disposable Medical Devices to customer and ISO13485 requirements.•Six Sigma Team Member - Performed FMEA of Receiving Inspection Process identifying non value added activities, documentation bottlenecks, equipment needs and dock to stock commodities. Planned and implemented reallocated resources and responsibilities to net a 70% gain in efficiency and throughput.•Investigated nonconforming material issues and customer complaints to determine root cause, develop and verify effective corrective & preventive (CAPA) actions eliminating recurrence and reducing costs.•Performed supplier, internal audits and assisted in Regulatory and Customer Audits to ISO 13485 / GMP 820 Quality Systems requirements for Medical Device. Issued audit reports and metrics.•Managed Calibration activities: Initiated procedures and work instructions, developed alternate suppliers and negotiated new calibration contracts to net 25% - 40% annual savings.•Utilized AGILE software to initiate ECO’s to issue Validation Protocols and Reports, Quality Plans, Raw Material Specifications, Part Numbers and Forms. Reviewed engineering designs and manufacturing documents for manufacturability, inspectability and conformance to GDT per ANSI Y14.5.•Supervised and trained 7 employees; conducted performance evaluations and disciplinary actions.

Poway

Managed facility utilizing Continuous Improvement and Lean methods to minimize cost and optimize the safe and efficient operations of production activities.•Developed and implemented ISO 9001:2000 Quality System successfully passing a USPS audit.•Researched and implemented engineering improvements resulting in $250K annual cost reductions.•Planned and implemented facilities improvements on time and under budget $50K.•Ensured compliance of international and domestic materials and processes including auditing suppliers •Planned and implemented supplier Kanban agreements resulting in raw material inventory reduction.•Managed 15 employees; conducted performance evaluations and disciplinary actions.•Assisted Sales and Marketing at trade show presentations.

San Diego

Ensured supply chain, production and test compliance for Class II Medical Devices to Engineering and ISO9001:2000 requirements.•Developed, implemented and maintained ISO 9001:2000, QSR/GMP 820 Quality Systems for Medical Device successfully passing FDA/FDB certification audits.•Researched, planned and initiated a $250K Annual cost reduction initiative for manufactured commodity.•Planned facilities improvements and capital equipment acquisition, completed under budget $25K.•Worked with Engineering and Supply Chain to audit, qualify, develop and manage suppliers. Performed internal audits, assisted in Regulatory and Customer Audits to ISO 9001 Quality Systems requirements•Utilized AGILE software to initiate ECO’s to issue Validation Protocols and Reports, Quality Plans, Raw Material Specifications, Part Numbers and Forms. Reviewed engineering designs and manufacturing documents for manufacturability, inspectability and conformance to GDT per ANSI Y14.5.•Investigated nonconforming material issues and customer complaints to determine root cause, develop and verify effective corrective & preventive (CAPA) actions eliminating recurrence and reducing costs.•QA member of cross functional team performing Verification and Validation IQ, OQ, PQ, activities of production equipment and FMEA of Manufacturing process.•Researched developed and managed Calibration Program for precision measuring equipment.•Managed and presented Quality Metrics to Management Team

Fallbrook

Ensured supply chain, production and test compliance to Engineering and ISO9001:1994 requirements.•Developed, implemented and maintained ISO9001:1994 Quality System•Investigated nonconforming material issues and customer complaints to determine root cause, develop and verify effective corrective & preventive (CAPA) actions eliminating recurrence and reducing costs.•Chaired Change Control Board reviewing engineering designs and manufacturing documents for manufacturability inspectability and conformance to GDT per ANSI Y14.5.•Managed a cross-functional team to perform FMEA’ to address design, safety and environmental issues.

San Marcos, Ca

Managed facility utilizing Continuous Improvement and Lean methods to minimize cost and optimize the safe and efficient operations of production activities.•Implemented then doubled the plastics recycling program resulting in earnings of $120K annually.•Planned and initiated facilities improvements $55K under budget.•Negotiated electrical rates with SDG&E for cost reduction of $6K annually.•Planned and scheduled production and inspection workload to support schedule.•Managed 50 employees; conducted performance reviews and disciplinary actions.