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Tier-1 brand and metro location but specialized regulatory skillset reduces broad competition.
Specialized regulated-QMS and software validation expertise reduces cross-industry transferability.
Explicit 8–10 years plus regulated QMS and validation expertise makes screening highly stringent.
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Develop and maintain validation procedures and standards for non-product software ensuring compliance throughout the validation lifecycle including planning, risk assessment, testing, and review.
Oversee quality assurance processes related to computerized systems and software applications, including reviewing and approving validation documentation and supporting audits and inspections.
Drive continuous improvement initiatives within QMS and mentor validation project team members to enhance quality performance and operational efficiency.
Bachelor's or Master's Degree in Mechanical Engineering, Industrial Engineering, Science, or equivalent.
8-10 years of experience in Quality Management Systems, Quality Audits, or equivalent roles in a highly regulated industry.
Experience with regulatory requirements, QMS, project management, and computer system assurance validation.
Onsite role requiring full-time presence at company facilities.
Experienced in managing software validation processes within regulated environments, especially non-product software.
Skilled in navigating regulatory compliance and audit processes related to quality management and computerized systems.
Capable of leading cross-functional teams, driving QMS improvements, and mentoring team members on validation lifecycle requirements.