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Tier-1 employer but specialized regulatory QMS role and seniority create moderate applicant competition.
Role requires regulated-industry QMS and validation expertise, limiting transferability across non-regulated industries.
Explicit 8–10 years plus mandatory regulated QMS and validation expertise makes shortlisting highly strict.
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Develop, implement, and maintain validation procedures for non-product software throughout its lifecycle, ensuring compliance with regulatory and quality standards.
Oversee quality assurance processes related to computerized systems and software applications including documentation review and approval, and support audits and inspections.
Drive continuous improvement initiatives within QMS and mentor validation project teams on lifecycle requirements.
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 in highly regulated industries.
Experience with software validation lifecycle, regulatory compliance, and quality audits.
Onsite role requiring work presence at company facilities at least 3 days per week.
Experienced in quality management for non-product software in regulated environments, with strong expertise in computerized system validation.
Operates with a detail-oriented and compliance-driven approach, capable of managing audit readiness and documentation quality.
Demonstrates leadership in mentoring teams and driving continuous process improvements within QMS frameworks.