Angelo Mattei

SUMMARY

PROFESSIONAL EXPERIENCE

• Devised and implemented improved documentation guidelines for determining cGMP/technical compliance during review of data generated for PM/Cals of process equipment resulting in decreased errors and reviewing time. Maintained an effective change control program.
• Effective in exception reporting of process deviations (OOT) and/or failure investigations, that may have impacted product quality. Thorough in determining RCA and proactive in implementing required CAPA.
• Instrumental in revising SOPs specific to Device and Pharmaceutical equipment. Expertise demonstrated in evaluating machine specifications, control systems, and accuracies of Reference Standards. Assisted with IQ/OQ/PQ of new and existing equipment.
• Consulted with team members in QA, Validation, and Regulatory Compliance in conducting internal audits and assisted with executing FDA Compliance protocols.
• Planner/Scheduler
• Implemented Maximo CMMS database system improving scheduling efficiency. Mechanic’s wrench time increased 36% and achieving maintenance excellence objectives.
• Diligent in coordinating/streamlining machining projects in the Alza fabrication department.

• Participated in implementation team for company ISO-9001 certification. Wrote and updated operating procedures, facilitated training, and performed departmental and vendor quality audits.
• Sr. Process Engineer/Manager
• Utilized SPC and DOE for cost reduction and Continuous Quality Improvement. Product yield improved from 96% to 99%.
• Trained production operators and process engineers on Standard Operating Procedures to comply with Military Standards in the assembly of High Reliability/Space Hybrid Microcircuit components.
• Researched and procured $200K in new capital equipment. Instrumental in coordinating deliveries and contractors. Set-up and qualified equipment prior to production use.

• Procured from and coordinated with over 50 vendors providing $500K of JIT inventory thereby ensuring a timely delivery.
• Maintained and documented ECOs for drawings, worked with machine, sheet metal, and plating shops to implement changes on specialized parts.
• Actively involved with assembling the components used in all phases of SMT equipment fabrication.
• Landec Corporation, Menlo Park, CA 1993-1995
• Manufacturing Technician
• Identified process problems, used in manufacturing medical devices used in the treatment of orthopedic injuries. Implemented corrective actions and reduced rejects by 20%.
• Purchased over $30K of raw materials weekly. Inventoried parts and performed cycle counts.

• Managed material science experiments for flat-screen display technologies and defense projects.
• Designed, consulted with engineers, and fabricated prototype parts for process and R&D equipment.

COMPUTER SKILLS

TRAINING

EDUCATION