Sr Manager QA Engineering

DexCom • San Diego, CA

13h • Onsite

About The Position

The Senior Manager, QA Engineering leads a team of Quality Engineers responsible for the development, qualification, validation, and implementation of high-volume manufacturing automation equipment used to support new product introductions and commercial manufacturing. This role provides strategic and technical leadership to ensure automation systems, manufacturing processes, and quality systems meet regulatory and business requirements while enabling scalable, efficient operations. The Senior Manager partners closely with Engineering, Operations, R&D and other cross-functional teams to drive quality, compliance, risk management, continuous improvement, and successful deployment of advanced manufacturing technologies.

Requirements

• Extensive experience leading Quality Engineering teams within a regulated environment and a demonstrated ability to develop talent, build engagement, and drive organizational performance.
• Deep knowledge of FDA 21 CFR 820, ISO 13485, Design Controls, Process Validation, Risk Management, and Quality Management Systems, and can effectively translate those requirements into business practices.
• Excel at influencing and partnering with leaders across Engineering, Operations, Manufacturing, and executive leadership to achieve strategic objectives.
• Effectively balance technical, regulatory, operational, and business priorities while making sound decisions in complex and rapidly changing environments.
• Proven track record of driving quality system improvements, compliance initiatives, inspection readiness programs, and operational excellence initiatives.
• Skilled in organizational leadership, resource planning, budget management, and prioritization across multiple programs and competing business needs.
• Foster accountability, collaboration, and continuous improvement while creating an environment that encourages innovation and employee development.
• Communicate with clarity, credibility, and influence at all levels of the organization, including senior leadership and external regulatory agencies.
• Leverage data, quality metrics, and risk-based decision-making to drive business outcomes and improve organizational effectiveness.
• Typically requires a Bachelor’s degree with 13+ years of industry experience.
• Requires a degree in a technical discipline.
• 5-8 years of previous people management experience.

Responsibilities

• Lead and develop a team of Quality Engineers responsible for supporting development of high-volume manufacturing automation equipment, new product introductions, equipment qualification, and process validation across multiple programs and sites.
• Establish the strategic direction for quality engineering activities, ensuring alignment with business objectives, regulatory requirements, and organizational quality goals.
• Provide leadership and oversight for Design Control, Design Transfer, Process Validation, and Manufacturing Quality activities, ensuring scalable and compliant commercialization of new products and processes.
• Partner with Engineering, Operations, R&D leaders to proactively identify and mitigate quality, compliance, and business risks throughout the product lifecycle.
• Drive a culture of continuous improvement by overseeing quality metrics, CAPA effectiveness, nonconformance management, and systemic problem-solving initiatives that improve product quality and manufacturing performance.
• Build organizational capability through coaching, mentoring, performance management, succession planning, and development of high-performing quality engineering teams.
• Ensure alignment and consistent execution of Quality Management System requirements across sites, functions, and programs, driving standardization and global best practices.
• Represent Quality Engineering during internal audits, customer audits, and regulatory inspections, providing leadership and ensuring effective preparation, response, and follow-through.
• Manage departmental priorities, resources, budgets, and staffing plans to support current operations and future business growth.

Benefits

• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager