Validation Engineer

Duties/Responsibilities:

• Review new and existing drawings as received from customers and evaluate for potential quality issues.
• Develop and execute IQ, OQ, and PQ validation protocols for production processes, equipment and software.
• Write reports summarizing results for equipment, process or software validation projects.
• Determine deliverables with the customer and cost estimate the sampling requirements and
• inspection activity.
• Review existing validation reports and identify/mitigate gaps for compliance to requirements
• Work with Q.A. Dept. on piece part inspections and capability studies of new mold and engineering changes to ensure all requirements are completed and approved.
• Conduct or lead corrective and preventive actions in quality systems or validations using problem solving techniques.
• Participate as an active new product development core team member.
• Process all stages of validation documents and oversee the completion and signatures.
• Support quality system projects and activities such as engineering change order support and complaint investigation support.
• Support FDA inspection readiness activities.
• Interfacing with customers, staff and fellow managers to establish and maintain validation schedules throughout the company.
• Ability to interact with customers in all necessary situations to keep them informed of progress and documentation status.
• Development of protocols and distributing inspection reports in a timely and cost-effective manner.
• Consults with customer on quality and inspection related issues.
• Knowledge of procedures and documentation for the quality validation of new products.
• Other duties as assigned by the Director of Engineering.

• Excellent written and verbal communication skills and highly effective time management skills.
• Ability to operate independently and as part of a team
• Independent problem-solving skills
• Proficient in root cause analysis, verification & validation, process flow mapping
• Technical and procedural understanding of customer requirements for part validation.
• Project management skills including planning, processing, organizing and tracking of all part validation activities.
• Knowledge of processes and procedures for cost estimating of validation work.

•  Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline and 3-5 years of process/software validation experience in a regulated industry
• Working knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD)

• Full benefit offerings including medical, dental, vision, and voluntary plans 
• Up to $85,000 annual