Caleb Richter Email & Phone Number

Carlsbad, California, United States

- Primary manufacturing engineer supporting operations in Abbott Vascular Temecula- Accountable for quality, safety, product output and yield for manufacturing line- Knowledge of statistics, GD&T, tolerance stack up analysis, Statistical Process Control “SPC”, fundamentals of Design of Experiments “DOE” and problem solving methodologies - Use of various inspections tools including but not limited to: pin gauge, caliper, micrometer, snap gauge, drop gauge, block gauge, optical comparator, vision system, etc.

Carlsbad, California, United States

• Drive safety improvements to promote a safe working environment• Work within QMS to effectively perform investigations and identify resolutions process failures and deviations• Participate in internal and external audits and respond to audit observations• Identify and implement appropriate corrective and preventative actions• Manage updates of manufacturing records such as WINs, SOPs, and batch records• Create new processes and/or improve processes within manufacturing and QC• Troubleshoot existing products and processes to recommend and develop/design engineering solutions to address capacity, cost, and quality issues• Prepare reports and present data to peers, supervisors, and other internal customers• Create and review project proposals and plans with stakeholders• Determine project specifications by reviewing performance standards, process requirements, and customer requirements• Manages project cost, documentation and deadlines to ensure on-time completion• Drive Practical Process Improvements (PPI) with a high level of team member involvement and engagement, and utilize lean methodologies to realize process efficiencies• Effectively communicate barriers or issues and obtain needed support for a resolution• Implement the following quality investigation methodologies; RCCM, RCA, Fishbone, 4M+E, CAPA / CA

Greater San Diego Area

• Perform PM services, repairs and root cause analysis in cGMP environments• Familiarity with relevant USP, FDA and CFR terminology and compliance• Perform instrument validation and generate associated documentation• Provide vendor support for a variety of quality and regulatory departments• Multitask with multiple instruments and customers• Time-management in fast-paced environment with changing priorities• Optimize workflow and find improvements for Suez and customers• Meet a variety of cleanroom requirements for instrumentation and documentation• Technical troubleshooting and data analysis in high pressure environments• Understand variety of product applications and the ensuing challenges• Technical, hands-on work using a variety of hardware and software

Rancho Santa Margerita, Ca

• Interact with FDA and other regulatory authorities during audits• Recommend design improvement based on post-market evaluations• Data analysis to support CAPA investigations• Weekly inspection of electrical and mechanical test fixtures• Daily collection and analysis of post market data to evaluate health of product line• Provide insight leadings to SOP updates• Meticulous documentation in SAP via controlled forms