Cirilo Custodio Email & Phone Number

California, United States

Sunnyvale, Ca, Us

Watford, Hertfordshire, Gb

Marlborough, Ma, Us

Issues Device History Records (DHRs) to meet production build plan. Manufactures under ISO 13485:2003 certified and FDA QSR (21 CFR 820) environment. Generates and reports monthly production numbers and sets monthly production goals. Addresses line support issues with Manufacturing Engineers. Use SPC to monitor key production processes. Trains, develops, and motivates assembly personnel to manufacture a Class III medical device. Conducts annual performance reviews for all assembly personnel and Material Coordinator. Monitor metrics for yields, cycle times, DHR completion accuracy, and throughput. Oversee domestic and international shipments in support of clinical investigational studies and pivotal trial. Interacts with FDA and external auditing agencies, conducts Process Auditing and participates in quarterly Internal Audits. Issues and approves purchase orders, continually evaluates raw material inventory levels, and monitors and reconciles Finished Goods inventory. Demonstrates strong knowledge of safety regulations and hazardous waste management.

Managed projects to increase production efficiencies and expand DNA synthesis and processing capabilities. Facilitated technology transfer, performed training, and directed scale-up activities. Monitored product quality and captured failure rates. Designed experiments and wrote reports aimed at maintaining high quality in a fast-turnaround business environment in Japan.

Venlo, Limburg, Nl

Managed projects bringing high throughput and low throughput DNA synthesis platforms to sister sites domestically and internationally. Performed set up activities. Trained staff to new synthesizer operation and maintenance procedures.

Managed multiple shifts for the DNA synthesis group in a high-volume, fast-turnaround manufacturing environment. Performed scale-up activities, scheduled maintenance, wrote SOPs, ordered parts and maintained inventory of parts. Evaluated work flow and prioritized orders to meet customer turnaround times.