Head of Product Quality

About the role

For our client, we are seeking a Head of Product Quality to join the team of a leader in the Retail & Consumer Goods space. This leader will own the company’s product quality strategy and quality management system for regulated hardware products. The role will partner closely with product development, engineering, and operations to strengthen design controls, risk management, and release readiness. This is a hands-on leadership position that requires independent judgment, strong regulatory discipline, and the ability to drive quality performance across the product lifecycle.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Own and improve the Quality Management System (QMS) in line with ISO standards.
• Define the quality policy and ensure the QMS evolves with products and regulations.
• Lead management review meetings to report on quality metrics and system performance.
• Review and approve test plans, ensuring methodologies are sound for product development.
• Manage design controls and make independent go/no-go calls on product releases.
• Oversee the risk management process aligned with ISO 14971 principles.
• Implement a formal document control system for specifications and records.

Qualifications

• 10+ years of quality engineering or systems experience in regulated hardware environments such as medical devices or similar fields.
• Hands-on experience with ISO 13485 and/or 21 CFR 820 quality management systems.
• Experience approving test plans and V&V documentation for physical or electromechanical products.
• Practical knowledge of document control, CAPA, nonconformance, and audit programs.
• Understanding of risk management according to ISO 14971 or equivalent standards.
• Ability to operate independently and make final quality decisions with minimal oversight.
• Bachelor’s degree in engineering, physical science, or a related technical field.

Benefits

• Competitive compensation, equity, and bi-annual performance reviews.
• Comprehensive medical, dental, and vision coverage fully funded.
• 401K plan for retirement savings.
• Generous paid time off.
• Paid parental leave.
• Monthly wellness reimbursement for health-promoting activities.
• Cell phone reimbursement for work-related communications.
• Employee product purchase program.
• Weekly catered lunches and free snacks and beverages.
• Dog-friendly office environment in San Francisco.
• Access to an Employee Assistance Program with online legal support.

Pay

$175,000 – $265,000 annually