Quality Systems Team Leader

About the role

Johnson & Johnson MedTech Cardiovascular is seeking a Quality Systems Team Leader to lead key site Quality System processes and a multidisciplinary team. The role focuses on strengthening compliance, improving quality performance and partnering with local and global functions to ensure effective, sustainable processes.

Key responsibilities

• Lead and continuously improve site Quality System processes, including CAPA, Quality Agreements, training, the Quality Manual, and document/records management.
• Manage CAPA governance, investigations, implementation plans, effectiveness checks, metrics, escalation and timely closure.
• Ensure Quality Agreements are aligned with company processes and supported by appropriate controls.
• Lead quality and cGMP training activities, coach employees and process owners on Quality System expectations.
• Maintain and improve Quality System procedures in line with regulations, standards and company requirements.
• Provide leadership for Enterprise Retention Schedule, Legal Hold preservation, and Vital Records inventory compliance.
• Oversee physical‑records lifecycle, including active onsite records, transfer, off‑site archiving and archive‑box monitoring.
• Partner with local and global stakeholders to resolve quality challenges, identify improvement opportunities and support audit readiness.
• Lead, coach and develop the Quality Systems team, building capability and accountability.

Required profile

• Bachelor’s degree or higher in engineering, science, quality, statistics or a related field.
• 2‑4 years experience leading quality assurance or Quality System activities in a regulated environment.
• 5‑7 years working knowledge of medical‑device or pharmaceutical Quality System requirements, including ISO standards and Quality System Regulation.
• Experience interacting with regulatory authorities, notified bodies or external auditors.
• Demonstrated leadership of people, projects or cross‑functional initiatives.
• Strong written and verbal English communication skills.

Required skills

• CAPA governance and implementation.
• Quality Agreements development and control.
• cGMP training design and delivery.
• Document and records management, including electronic and physical records.
• Knowledge of ISO standards and Quality System Regulation requirements.
• Data analysis and statistical tools for quality performance monitoring.