• 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:
• Applicable Software Packages (MS Suite, Agile)
• 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