Location: Colorado Springs CO
Duration: 5 months
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.
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