Quality Manager

About the role

Johnson & Johnson MedTech Electrophysiology is looking for a Quality Manager to lead and coordinate quality assurance programs for its manufacturing operations in Costa Rica. The role ensures continuous production quality, regulatory compliance, and drives improvement initiatives across the site.

Key responsibilities

• Plan, coordinate and direct quality assurance programs, supervising Quality Engineers, Team Leaders, Supervisors and Technicians.
• Lead quality improvement initiatives using PDCA, Six Sigma, Kaizen, Lean and benchmarking to reduce costs and enhance product quality.
• Establish and monitor quality metrics, support product and process improvement projects, and manage change requests in the PLM system.
• Oversee non‑conformance investigations, CAPA, customer complaints, material segregation and classification of defects.
• Ensure compliance with QSR, ISO 13485 and other regulations; lead audit preparations and act as subject‑matter expert for regulatory agencies.
• Define, monitor and administer the department budget, approving purchase orders and expense reports.
• Validate processes, maintain PFMEAs, quality control plans and risk assessments (FMEA) throughout the product life‑cycle.

Required profile

• Proven experience leading quality teams in a regulated manufacturing environment.
• Strong knowledge of medical device regulations (QSR, ISO 13485) and audit processes.
• Ability to manage budgets, drive continuous improvement and mentor staff.
• Experience with change management and documentation in PLM systems.

Required skills

• Six Sigma
• Lean
• Kaizen
• PDCA
• PLM system usage
• FMEA / PFMEA
• Process validation
• ISO 13485
• QSR compliance