This is a 6 - 9 month initial contract. Key Responsibilities: Develop and maintain Quality System procedures. Investigate and troubleshoot validation issues related to components, equipment, and performance processes. Monitor and ensure the compliance status of quality records. Write, review, approve, and execute documentation for new and current validation procedures and technical reports for equipment, products, and processes. Assist in establishing corporate validation policies. Maintain the quality and compliance of Procedures, work instructions, and training materials. Track, communicate, and report on status, metrics, trends, potential issues, and improvement initiatives. Demonstrate in-depth understanding of design controls and design transfer. Participate in or lead risk analyses and FMEAs (Failure Mode and Effects Analysis). Interface with senior management on significant matters, coordinating activities across organizational units as needed. Mentor less-experienced staff and potentially supervise technical employees. Skills and Qualifications: 5 plus years of experience in a similar role. Strong background in quality validation within a regulated industry. Experience with risk analysis, FMEAs, and design controls. Excellent documentation and communication skills. Ability to work collaboratively across teams and mentor junior staff. Skills: Quality Systems Procedures Validation Documentation Design Controls Design Transfers