Validation Engineer

Work Schedule

Environmental Conditions

Job Description

Responsibilities:
• Directly and actively support site validation program (product, process, equipment and software, test methods)
• Leads Root cause analysis and implementation of corrective action for process related concerns
• Assists Quality Manager or Quality Systems lead in establishing, implementing, maintaining, and improving the quality management system
• Develops and implements continuous improvement activities to enhance the quality system, such as Six Sigma, 5S, Lean Manufacturing methods, etc.
• Develops and implements technical quality training to build internal capability in areas of expertise such as risk management per ISO 14971, validation, statistical techniques, Quality sampling plans, RCA and investigation, etc...
• Supports development and improvement of inspection methods, including but not limited to Test Method Validation
• Collaborate with Engineering and Operations to ensure new product transfers to Production are in accordance with approved protocols
• Supports Quality Inspectors to ensure that products and processes align with the relevant requirements of the quality management system
• Drives resolution of failure analysis, corrective and preventive action to respond to internal and/or external customer complaints
• Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions
• Manage individual complaint investigation workflows into a comprehensive summary of the findings for inclusion in complaint files and ensure timely evaluation, escalation, and closure of complaint files
• Ensure timely resolution of customer complaints, supplier failure, corrective actions and preventive actions                                             

Minimum Requirements/Qualifications:
• Bachelor’s degree in Science or Engineering field
• Minimum 3 years of experience in Medical Devices is preferred
• Minimum 3 years of experience in quality system maintenance is preferred
• Excellent problem solving and analytical skills and developed understanding of risk management
• Excellent oral and written communication skills             • Excellent computer skills
• Ability to work independently and proactively
• Demonstrated leadership ability
• Experience in Medical Devices (PFMEA, Control Plan, CAPA)
• Working knowledge of ISO 9001 and ISO 1348
• Experience working in a GMP environment such as Medical Device industry or plastic consumables
• Statistical Analysis Tools such as Minitab or JMP, SAP, TrackWise, Microsoft Excel, Visio, Power Point, and MS Project

Preferred:
• ASQ Certified Quality Engineer is preferred or similar certification
• Six Sigma Certification is desirable
• Lean Manufacturing working experience