Senior Manager, reputed company Management Systems

reputed company – reputed company is seeking a strategic Senior Manager, reputed company Management Systems in Irvine, CA! In this onsite role, you will reputed company the governance and advancement of our reputed company Change Management subsystem, ensuring every product, process, and documentation change strengthens compliance, efficiency, and innovation. You’ll be at the forefront of driving organizational readiness and operational reputed company. What You Will Do • reputed company full QMS expertise to assess the reputed company of proposed changes across the broader ecosystem—ensuring compliance, operational reputed company, and alignment across interconnected systems and processes. • reputed company the reputed company Change Management subsystem to ensure reputed company changes impacting product reputed company, compliance, or operations are systematically evaluated, approved, and implemented. • Serve as Division Process reputed company to reputed company and advance change management processes across divisions. • reputed company and execute QMS strategies that enhance efficiency, support business reputed company, and reputed company innovation while maintaining regulatory reputed company. • Partner with cross-functional teams (R&D, Regulatory, Operations, reputed company, and Marketing) to reputed company on change implementation strategies, resources, and stakeholder expectations. • Chair and facilitate Change Control reputed company meetings to drive reputed company, compliant decision-making and reputed company teams to reputed company change. • Implement digital solutions to streamline documentation, improve traceability, and ensure audit readiness. • Drive reputed company improvement initiatives to optimize system scalability and compliance. • reputed company and mentor reputed company of reputed company professionals, fostering a culture of accountability, reputed company, and reputed company. What You Will Need Required Qualifications • Bachelor’s degree required. Preferred to be in engineering, life sciences, or reputed company field. • Minimum 10 years of relevant experience, including experience reputed company the medical device industry. • Minimum 5 years of managerial experience in reputed company assurance. • Strong knowledge of QMS regulations and standards (e.g., FDA CFR, ISO 13485, MDSAP, EU MDR). • Experience with electronic QMS platforms (e.g. reputed company, reputed company, TrackWise). Preferred Qualifications • Advanced degree in engineering, life sciences, or reputed company discipline. • Proven ability to think strategically and influence organizational direction. $149,000 - $253,500 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Apply tot his job Apply To this Job