Process Engineer Consultant

Position: Process Engineer Consultant
Location: Colorado Springs, CO
Duration: 6-12 months (Extendable)

Description 
 • Extensive experience in CAPA and other Quality Systems. 
 • Provide perspective and input regarding regulations and industry best practice in CAPA and other Quality Systems. 
 • Participate in CAPA team in the identification and prioritization of CAPAs requiring closure. 
 • Support CAPA Lead Investigators and teams in the root-cause analysis, planning, coordination, execution, and closure of identified CAPAs. 
 • Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification. 
 • Experience in compliance writing 
 • Develop and implement updates to Quality System Standard Operating Procedures (SOPs), as well as complete remediation of legacy Quality Records, as required. 
 • Develop and implement stand-alone CAPA action plans and reports. 
 • Interface well with a team of other Quality, Manufacturing, and R&D Engineers. 
 • Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Experience with ISO 14971, Risk Management for medical devices. 
 • Develop, implement, and monitor quality metrics. Communicate status and progress. 
 • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. 
 Supervisory Duties: None 
 Material and Equipment Directly Used: 
 • Computers 
 • Applicable Software Packages (MS Suite, Agile) 
 Education/Experience Necessary: 
 • Typical experience required is a minimum of 5 years as an Engineer in a related field, BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline, preferred. 
 • Solid experience in Risk Management for medical devices ISO 14971 desired 
 • Application and leading problem-solving, root cause analysis and related Corrective and Preventive Action (CAPA) 
 • Regulated industry preferred 
 • Statistical analysis, JMP software preferred, 3D modeling, Solidworks 

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