As a Sr. Manager, Quality Systems, you will lead and oversee the Global Training and Global 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.

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: Lead and develop teams, support external audits, and stay updated on regulatory changes. 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, compliance, and process improvement within a regulated industry.
• Ability to thrive in a fast-paced environment, collaborating across teams.