Quality Systems Director (Medical Devices)

Location: Remote within the United States; role location listed as Los Angeles, California

Salary: $186,000–$318,000 USD annually for California locations

Company

hirify.global develops full-stack insulin delivery solutions, including intelligent dosing systems, predictive insights, and support for people living with diabetes.

What you will do

• Lead the global Quality Management System framework, governance, regulatory compliance, and executive oversight.
• Evaluate QMS effectiveness, identify systemic risks, measure performance, and drive continual improvement across global quality organizations.
• Direct global quality training governance, including competency, qualification, and training effectiveness requirements.
• Oversee QMS change management and assess emerging and revised regulatory requirements, standards, and industry expectations.
• Drive harmonization, simplification, quality objectives, metrics, executive reporting, and audit and inspection readiness.
• Lead cross-functional governance forums and develop the global Quality Systems organization, including capability development and succession planning.

Requirements

• Bachelor’s degree with 10+ years of quality systems experience and 7+ years of people management experience, or an advanced degree with 8+ years of quality systems experience and 7+ years of people management experience.

Nice to have

• Experience leading Quality Systems teams in the medical device industry.
• Experience leading and supporting FDA audits.
• Previous post-market surveillance experience.
• Experience leading large organizations in quality systems strategy and execution.
• Experience developing global quality systems strategy.

Culture & Benefits

• Full-time employment with flexible workplace arrangements.
• Competitive compensation with short-term and annual long-term incentive plans.
• Benefits for regular employees working 20 or more hours per week include health, dental, vision, HSA, FSA, life insurance, disability coverage, paid time off, holidays, and a 401(k) with company match.
• Additional benefits may include an Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement, and Capital Accumulation Plan, subject to eligibility.
• Reasonable accommodations are available for qualified individuals with disabilities.