Director of Quality Operations

About the role

The Director, Quality Operations will provide strategic and operational leadership for all quality functions at Insulet’s new Costa Rica manufacturing site. The role starts remotely and will transition onsite once the facility is operational.

Key responsibilities

• Lead Quality Engineering, Assurance, Control, Incoming Quality and Quality Systems across the site.
• Serve as primary quality representative during FDA, MDSAP, ISO 13485, customer and corporate audits.
• Oversee CAPA, non‑conformance management, validation, environmental monitoring, training and release processes.
• Develop and execute the site quality strategy aligned with global objectives and support site expansion, capacity growth and commercialization programs.

Required profile

• Bachelor’s degree in Engineering, Science or related field; advanced degree preferred.
• 12+ years progressive medical‑device quality leadership experience, including 10+ years managing quality teams in regulated environments.
• Proven ability to lead through inspections, audits and organizational change.

Required skills

• Strong knowledge of FDA Quality System Regulations (QSR), ISO 13485 and MDR.
• Experience with risk management, validation and quality engineering principles.
• Expertise in CAPA, audit management and regulatory compliance.