Director, Quality Operations

Job Summary

Work Arrangement: Due to the launch of our new greenfield site, this role will start as remote. Candidates are expected to transition to an onsite work arrangement once the facility is ready

Required Experience & Qualifications

• 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.

Position Overview

The Director, Quality Operations provides strategic and operational leadership for all Quality functions at Insulet Costa Rica. This role is accountable for product quality, regulatory compliance, quality systems effectiveness, and quality culture across a large-scale medical device manufacturing site. The position serves as a key member of the site leadership team, ensuring compliance with FDA, ISO 13485, MDR, and applicable global regulations while enabling business growth, operational excellence, and successful site expansion.

Key Responsibilities

• 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 ensure alignment with Insulet's global quality standards and strategic objectives.

• Develop and execute the site Quality strategy aligned with global Quality and business objectives.

• 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 practices and data-driven decision making throughout manufacturing operations.

• Own multiple quality budgets and establish performance metrics that improve customer satisfaction, compliance, and operational effectiveness.

Leadership Competencies (Aligned to Insulet Leadership Model)

• Strategic Thinking: Establishes a long-term quality vision that supports business growth, emerging technologies, and customer requirements.

• Global Perspective: Operates effectively within a global matrix organization and drives harmonization of quality practices across regions.

• Innovation: Champions quality innovation, digitalization, automation, and continuous improvement initiatives.

• Financial Acumen: Balances compliance, risk, operational performance, and cost effectiveness when making decisions.

• Customer Focus: Ensures quality systems and manufacturing processes consistently meet customer and patient expectations.

• Analysis and Problem Solving: Utilizes statistical, operational, and quality data to identify root causes and implement sustainable solutions.

• Execution Excellence: Drives accountability, speed, and disciplined execution against commitments and quality objectives.

• Relationship Building: Builds strong partnerships across functions, cultures, and organizational levels.

• People Development: Develops future leaders through coaching, succession planning, talent reviews, and capability building.

• Communication: Clearly communicates quality risks, priorities, and strategic objectives to executive leadership and teams.

• Engagement: Creates a culture of inclusion, accountability, ownership, and continuous improvement.

• Adaptability and Courage: Leads effectively through ambiguity, growth, audits, organizational change, and business challenges.

• Influence and Collaboration: Gains alignment across stakeholders without direct authority and promotes effective cross-functional decision making.

Required Experience & Qualifications

• 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.

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.