Validation Engineer
1st shift
E-Verify
Location: Elgin, IL | On-Site
- Participate in projects/program management, review new and existing drawings as received from customers and evaluate potential quality issues.
- Develop and execute IQ, OQ, and PQ validation protocols for production processes, equipment and software in a timely and cost-effective manner.
- 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 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.
- Consults with customers on quality and inspection-related issues.
- Manages and holds project meetings with customers.
- Other duties as assigned by the Director of Engineering.
Required Skills/Abilities:
- 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 include planning, processing, organizing and tracking of all part validation activities.
- Experience processing data in MiniTab software and correlate P values.
- 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)
- Prolonged periods sitting at a desk and working on a computer.
- Office environment.
- Must be able to lift 15 lbs.
- Must be able to access and navigate each department at the organization’s facilities.
