Quality Systems Lead

About the role

The Quality Systems Lead will act as the champion and subject‑matter expert for quality systems and compliance programs, ensuring the site meets medical‑device regulatory requirements (FDA, ISO 13485, ISO 9001). This role drives continuous improvement, supports product releases, and collaborates across functions to maintain a robust quality management system.

Key responsibilities

• Lead all activities within the Quality Systems function, including document control, training, CAPA, change control, deviation handling, supplier audits, and electronic system validation.
• Maintain accurate regulatory contact and submission logs and provide guidance to internal project teams.
• Review, validate, and ensure software implementations comply with applicable standards and regulations.
• Negotiate and resolve issues with regulatory agencies and ISO registrars for current and future submissions.
• Support marketed products by reviewing engineering changes, labeling, promotional material, and documentation requiring government approval.
• Propose and execute quality system improvement initiatives and maintain Business Continuity Planning programs.
• Write, review, and approve validations in line with customer and regulatory requirements.
• Establish, maintain, and report quality system metrics to local teams, management, and global business units.
• Facilitate prioritization and resource discussions with Change/Improve stakeholders.
• Manage expenses, support budget planning, and drive site‑wide process improvement opportunities.

Required profile

• Proven expertise as a subject‑matter expert in quality systems and compliance for medical‑device environments.
• Strong knowledge of U.S. FDA regulations, ISO 13485, and ISO 9001 standards.
• Experience leading regulatory submissions, negotiations with agencies, and ISO registrars.
• Ability to support product lifecycle activities, including engineering changes and labeling approvals.
• Experience developing and maintaining Business Continuity Planning programs.

Required skills

• FDA regulatory compliance
• ISO 13485 implementation
• ISO 9001 implementation
• Electronic system validation
• Document and data control
• CAPA (Corrective and Preventive Action) management
• Change control processes
• Supplier audit management
• Quality metrics reporting