Kirti Shah Email & Phone Number

Beverly Hills, Ca, Us

Brea, California

Developed and implemented quality systems for customer feedback, corrective and preventive actions (CAPA) and quality measurements and reporting.• Developed and implemented Global Quality system process that includes Customer feedback (CF), Corrective & Preventive actions (CAPA), Audits and Management reviews with the FDA 21 CFR part 11 requirements and is in current use with 6000+ users.• Served as Project Leader for developing and implementing:  Business Objects reporting tool for quality. Developed 300+ reports for quality monitoring Customer regulatory E-Mail notification and customer acknowledgement system for product recall and corrective action (PCA)• Developed common metrics for measuring quality at all sites globally. The metrics are used as reporting tool for quality and business goals to CEO and Board of Directors.• Core team member for the evaluation of Product Life Cycle Management systems (PLM); evaluated Oracle Agile PLM system.• Quality system management representative for Logistics and Distribution.

Brea, California

Managed supplier quality program at all manufacturing sites. • Served as Project Leader for Manufacturing quality system: Developed quality system to document receiving inspection plans and records, parts rejection during manufacturing process, disposition information and corrective actions  Implemented manufacturing quality system at seven domestic sites plus four international sites in Europe and Asia Created training program and trained over 2000 employees at all manufacturing sites• Established common Supplier Quality program, procedures, audit and supplier score card system at all manufacturing sites.• Developed field service quality measurements and presented at Quality Excellence meetings, reducing service cost for all instruments and improving quality.• Compiled/analyzed quality reports from 11 manufacturing sites and presented data at the quality systems management review (QSMR) to company senior management.

Brea, California

Managed supplier quality program for Chemistry business center in Brea CA.• Conducted supplier quality audit/capability assessment of suppliers.• Established all process controls and procedures for product transfer from Puerto Rico, resulting in successful completion of outsource to DIBA.• Served as Project Leader for outsourcing PC Board manufacturing to Flextronics.• Successfully implemented quality process and procedures to meet ISO 9001 requirements at company headquarter and Chemistry business center.• Developed and facilitated classes for GMP, Total Quality Control (TQC) and Continuous Process Improvements (CPI).

Brea, California

Managed Test Engineering, Systems Technical Support and Software engineering groups that included staff of 34 Engineers and Technicians (four direct reports and 30 indirect reports).

Brea, California

Managed Test Engineering groups that included staff of 21 Engineers and Technicians (Three direct reports and 18 indirect reports).

Master Of Business Administration (Mba)

Bachelor Of Engineering (B.E.), Electrical And Electronics Engineering

Master Of Science (Ms), Electrical And Electronics Engineering