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

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