GLAUKOS Sr. Manager Global Quality Training & Document Control (San Clemente, CA) How Will You Make an Impact? As a Sr. Manager Global Quality Training & Document Control, you will lead and oversee the Global Quality Training and Document Control teams, ensuring compliance with regulatory requirements and maintaining high-quality standards. You will drive continuous improvement initiatives, collaborate cross-functionally, and enhance quality system effectiveness to support medical devices and combination products. The ideal candidate will have extensive experience in quality management, strong leadership skills, and a deep understanding of quality systems and processes. What Will You Do?
- Quality System Management: Develop, implement, and maintain quality management systems (QMS), ensuring compliance with industry standards. Lead audits, track performance metrics, and drive process improvements.
- Document Control: Oversee policies, procedures, and compliance related to document control, records retention, and batch record management. Manage team training and CAPA processes.
- Training: Design, implement, and optimize company-wide quality training programs using Learning Management Systems (LMS). Ensure compliance with FDA/ISO and industry regulations.
- Leadership & Compliance: Establish and install a vision for the Training and Document Control teams, defineobjectives, manage team performance and coordination of assignments. Lead, coach, mentor, and develop teams, present quality performance metrics to top management and foster a culture of engagement and transparency.
How Will You Get Here?
- Bachelor's degree required.
- 9+ years of industry experience, with 2+ years in management.
- Strong documentation, organizational, and communication skills.
- Experience in quality systems, document control, and process improvement within a regulated industry.
- Ability to thrive in a fast-paced environment, collaborating across teams.
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