Director – Quality Operations

Insulet Corporation

. Provide strategic and operational leadership for all Quality functions at Insulet Costa Rica.

Posted 10/5/2026full-timeHeredia • Costa RicaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive leadership in Quality functions within the medical device industry, focusing on compliance with FDA Quality System Regulations and ISO 13485 standards. Proven ability to drive quality strategy, risk management, and continuous improvement initiatives while developing future leaders in a regulated manufacturing environment.

Highest-signal resume keywords

Quality Engineering LeadershipFDA Quality System RegulationsISO 13485 ComplianceRisk Management ExpertiseQuality Assurance and Control

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Strategy DevelopmentCAPA ManagementValidation ProcessesNonconformance ManagementEnvironmental MonitoringData-Driven Decision MakingQuality Metrics EstablishmentManufacturing Quality ResponsibilityRegulatory Audit LeadershipQuality Innovation

Soft Skills

Coaching and MentoringTalent DevelopmentCross-Functional CollaborationChange ManagementContinuous Improvement Mindset

Industry Keywords

Medical Device QualityMDSAP AuditsCustomer AuditsOrganizational ChangeSite Expansion

About the role

Key responsibilities & impact

Provide strategic and operational leadership for all Quality functions at Insulet Costa Rica.
Lead Quality Engineering, Quality Assurance, Quality Control, Incoming Quality, and Quality Systems functions across the Costa Rica manufacturing site.
Partner with Global Quality, Operations, Supply Chain, Regulatory, and Engineering teams to align with global quality standards and strategic objectives.
Develop and execute the site Quality strategy.
Serve as the primary Quality representative during FDA inspections, MDSAP audits, ISO 13485 certification audits, customer audits, and corporate assessments.
Provide executive oversight of CAPA, nonconformance management, management review, audits, complaints, validation, environmental monitoring, training, and release processes.
Lead quality readiness activities for site expansion, capacity growth, inspections, certifications, and commercialization programs.
Ensure robust risk management and data-driven decision making throughout manufacturing operations.
Own multiple quality budgets and establish performance metrics that improve customer satisfaction, compliance, and operational effectiveness.
Develop future leaders through coaching, succession planning, talent reviews, and capability building.
Promote quality innovation, digitalization, automation, and continuous improvement initiatives.

Requirements

What you’ll need

Bachelor's degree in Engineering, Science, or related discipline; advanced degree preferred.
12+ years of progressive medical device quality leadership experience, including significant manufacturing quality responsibility.
10+ years leading managers and professional quality organizations in regulated environments.
Strong knowledge of FDA Quality System Regulations, ISO 13485, MDR, risk management, validation, and quality engineering principles.
Experience supporting site start-ups, transfers, rapid-growth operations, or large-scale manufacturing expansions preferred.
Demonstrated ability to lead through inspections, customer audits, regulatory audits, and organizational change.

Benefits

Comp & perks

Remote work arrangement at the start of the role
Potential transition to onsite work once the new facility is ready