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.

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

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

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