Premarket Quality Engineering Director (Medical Devices)

TL;DR

Premarket Quality Engineering Director (Medical Devices): Leading the Premarket Quality Engineering function to deliver innovative medical products with an accent on design controls, risk management, and regulatory compliance. Focus on building high-performing teams, driving cross-functional collaboration, and ensuring patient safety throughout the product development lifecycle.

Location: Onsite in Santa Ana, CA

Salary: $198,400 – $297,600

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Lead and mentor a high-performing global organization of quality engineers and technical leaders.
• Provide strategic leadership for design control activities, risk management, and design verification.
• Partner with R&D, Regulatory, and Operations to drive effective decision-making and quality excellence.
• Define and execute operational aspects of product development programs, including budget and resource forecasting.
• Ensure proactive integration of quality standards into all phases of new product development.
• Develop strategic initiatives to strengthen organizational capabilities and operational excellence.

Requirements

• Bachelors degree required
• Minimum 10 years of relevant experience with 7+ years of managerial experience (or advanced degree with 8+ years relevant experience).
• Must be based in or able to work onsite in Santa Ana, CA.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Demonstrated expertise in design controls, risk management, and product development quality.

Nice to have

• Experience supporting Class II and/or Class III medical devices.

Culture & Benefits

• Competitive salary and short-term/long-term incentive plans.
• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and well-being programs.
• Commitment to diversity, inclusion, and equal employment opportunity.