Premarket Quality Engineering Director (ICT), Santa Ana, CA
About The Position
In this role, you will lead the Premarket Quality Engineering function and partner 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. You will be responsible for driving 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. As the leader of the Design Assurance Engineering organization, you will build, develop, and sustain a high-performing team with the capabilities, expertise, and capacity required to support current and future product development programs. You will 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. You will 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. Through strong leadership and influence, you will help create an environment where cross-functional teams work together seamlessly to achieve program milestones and business objectives. In addition, you will 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. This role requires a forward-looking business mindset, balancing near-term program execution with long-term organizational development, talent strategy, and continuous improvement opportunities that enhance product development effectiveness and quality outcomes. The successful candidate will be a strategic people leader with a passion for developing talent, building strong teams, driving collaboration, and delivering innovative products to market that improve the lives of patients around the world. This position is onsite, based in Santa Ana, CA.
Requirements
- Bachelors 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.
Nice To Haves
- Experience supporting Class II and/or Class III medical devices
- Demonstrated expertise in design controls, risk management, and product development quality
Responsibilities
- Leads Premarket Quality Engineering teams to evaluate, develop and manage projects for new product development and ongoing lifecycle management of products, processes and therapies.
- Defines and executes operational aspects of product development programs including: schedule, project risk identification and mitigation plans, issue management, program management owned deliverable, budget and resource forecasting
- Monitors program progress and status through defined program objectives, KPIs, schedule progress, risk burndown, and effective issue mitigation and resolution strategies
- Develops mechanisms for tracking program performance, ensuring accountability, and enabling proactive intervention
- Drive strategic and executional alignment across R&D, Quality, Regulatory, Operations, and other partner functions within program team
- Creates clear and concise program updates, risks, and recommendations for use in communication with leadership
- Demonstrates strategic thinking in establishing and managing program plans, requirements, and execution strategies that are aligned to the business priorities
- Ensure compliance with design controls requirements, quality systems, and regulatory requirements.
- Acts as subject matter expert to the team in the Product Development Process (PDP)
- Leads, develops, and mentors a high-performing global organization of quality engineers, managers, and technical leaders.
- Fosters a culture of inclusion, accountability, innovation, collaboration, and continuous improvement.
- Builds organizational capability in systems engineering, software quality, advanced quality methodologies, and risk management.
- Develops future leaders through coaching, succession planning, and talent development initiatives.
- Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
- May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
- Oversees the investigation and evaluation of existing technologies.
- Guides the conceptualization of new methodologies, materials, machines, processes or products.
- Directs the development of new concepts from initial design to market release.
- Manages feasibility studies of the design to determine if capable of functioning as intended.
- Monitors documentation maintenance throughout all phases of research and development.
- Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Manager
