Global Head of Product Quality & Risk

Abel 2 Recruit, LLC; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Abel 2 Recruit, LLC is representing an international medical technology company seeking a senior Quality leader to shape and lead its global Product Quality, Risk & Compliance agenda at a pivotal growth stage. The role has global accountability for product quality, risk management and regulatory compliance across the full lifecycle.

The successful candidate will combine deep technical expertise with strategic business acumen, oversee design controls, software quality, and regulatory

Qualifications

• Senior leadership experience in medical device quality and regulatory environments.
• Proven track record overseeing design controls, risk management and software quality.
• Experience interacting with FDA and notified bodies is highly desirable.

Responsibilities

• Provide global leadership across Product Quality, Design Quality and Design Assurance.
• Oversee Product Risk Management and lifecycle governance.
• Lead Software Quality and product cybersecurity.
• Drive regulatory compliance and inspections readiness across markets.
• Scale the global Quality operating model and governance.

Skills

Senior Quality leadership

Medical devices

Regulatory inspections

FDA interactions

Quality governance

Design controls

Product quality

Job description

An international medical technology company is seeking a senior Quality leader to shape and lead its global Product Quality, Risk & Compliance agenda at an important stage of growth and transformation.

The role has global accountability for product quality, product risk and compliance, ensuring that regulatory, environmental and product requirements are embedded across the full product lifecycle.

This is a high-impact leadership role for an experienced medical-device Quality executive who combines deep technical expertise with commercial judgement, strong executive presence and a passion for building high-performing organizations.

The opportunity:

You will provide global leadership across:

• Product Quality, Design Quality and Design Assurance
• Product Risk Management and lifecycle governance
• Software Quality and product cybersecurity
• Product, materials and environmental compliance
• Post-market quality intelligence and product performance
• Regulatory inspections and notified-body interactions
• Quality transformation, continuous improvement and organizational effectiveness

You will act as a senior Quality partner to Product Development, Engineering, Regulatory, Operations, Supply Chain and other business leaders, ensuring quality and risk considerations are embedded in product and business decisions.

A key part of the mandate will be to strengthen and scale the global Quality operating model, clarify governance and decision rights, develop leadership capability and introduce more effective, data-driven and risk-based ways of working.

What we are looking for:

We are interested in leaders who bring:

• Significant senior Quality leadership experience within medical devices
• Strong, demonstrable experience with Class III products
• Deep expertise in design controls, design assurance and product risk management
• Experience with medical-device software Quality and validation
• Experience with product, materials or environmental compliance
• Strong exposure leading FDA and other regulatory inspections and notified-body audits
• Experience leading global, matrixed Quality organizations
• A track record of transformation, continuous improvement and organizational change
• The credibility to make, communicate and defend complex Quality decisions with senior executives and technical stakeholders
• A Six Sigma Black Belt or equivalent level of expertise is highly relevant.

The leadership challenge:

This is not a traditional compliance-focused Quality role. The successful leader will combine technical depth with a strong product and business orientation, challenging established thinking while maintaining an uncompromising focus on patient safety, product quality and regulatory compliance.

The role offers the opportunity to influence product strategy, strengthen organizational capability and help build a scalable global Quality function for the next phase of the company's development.

Our client:

Our client is an international medical technology company developing and commercializing innovative technologies designed to address significant unmet needs in healthcare.

With a growing global footprint and a strong focus on innovation, the organization is entering an important phase of development and is investing in the capabilities, leadership and infrastructure required to support its next stage of growth.

The company combines a highly science- and technology-driven environment with a strong commitment to quality and continuous improvement.