Premarket Quality Engineering Director (ICT), Santa Ana, CA

About the role

This role leads the Premarket Quality Engineering function and partners with cross-functional program teams to deliver innovative products that improve patient outcomes while ensuring compliance with all applicable regulatory requirements, quality standards, and business objectives.

Responsibilities

• Evaluate, develop and manage projects for new product development and ongoing lifecycle management of products, processes and therapies.
• Define and execute operational aspects of product development programs including: schedule, project risk identification and mitigation plans, issue management, program management owned deliverables, budget and resource forecasting.
• Monitor program progress and status through defined program objectives, KPIs, schedule progress, risk burndown, and effective issue mitigation and resolution strategies.
• Develop mechanisms for tracking program performance, ensuring accountability, and enabling proactive intervention.
• Drive quality excellence throughout the product development lifecycle, enabling successful and timely product launches while maintaining the highest standards of patient safety, product quality, and regulatory compliance.
• Build, develop, and sustain a high-performing team with the capabilities, expertise, and capacity required to support current and future product development programs.
• Provide strategic and operational leadership for design control activities, risk management, design verification, test method development, and test method validation, ensuring quality is proactively integrated into all phases of new product development.
• Collaborate closely with leaders and stakeholders across Research & Development, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, Program Management, and Operations to drive effective decision-making, manage quality risks, and foster a culture of partnership, accountability, and continuous improvement.
• Create an environment where cross-functional teams work together seamlessly to achieve program milestones and business objectives.
• Partner with site and functional leadership teams to develop and execute strategic initiatives that strengthen organizational capabilities, improve development processes, advance operational excellence, and position the business for future growth.
• Lead, develop, and mentor a high-performing global organization of quality engineers, managers, and technical leaders.
• Foster a culture of inclusion, accountability, innovation, collaboration, and continuous improvement.
• Develop future leaders through coaching, succession planning, and talent development initiatives.

Requirements

• Bachelor's degree required.
• 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience.

Qualifications

• Experience supporting Class II and/or Class III medical devices.
• Demonstrated expertise in design controls, risk management, and product development quality.

Skills

• Strategic thinking.
• Leadership and influence.
• Collaboration and teamwork.
• Forward-looking business mindset.
• Technical quality assurance and control systems.
• New methodology and product development.
• Feasibility studies and market release.
• Project management and risk management.
• Design control and regulatory compliance.
• Talent development and succession planning.

Benefits

Learn more about our benefits here.

Pay

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Schedule

The role is onsite, based in Santa Ana, CA.