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.
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