Meet the Team: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.
Where You Come In- You 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.
- You establish the strategic direction for quality engineering activities, ensuring alignment with business objectives, regulatory requirements, and organizational quality goals.
- You 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.
- You partner with Engineering, Operations, R&D leaders to proactively identify and mitigate quality, compliance, and business risks throughout the product lifecycle.
- You 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.
- You build organizational capability through coaching, mentoring, performance management, succession planning, and development of high-performing quality engineering teams.
- You ensure alignment and consistent execution of Quality Management System requirements across sites, functions, and programs, driving standardization and global best practices.
- You represent Quality Engineering during internal audits, customer audits, and regulatory inspections, providing leadership and ensuring effective preparation, response, and follow-through.
- You manage departmental priorities, resources, budgets, and staffing plans to support current operations and future business growth.
What Makes You Successful- You have extensive experience leading Quality Engineering teams within a regulated environment and a demonstrated ability to develop talent, build engagement, and drive organizational performance.
- You possess 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.
- You excel at influencing and partnering with leaders across Engineering, Operations, Manufacturing, and executive leadership to achieve strategic objectives.
- You effectively balance technical, regulatory, operational, and business priorities while making sound decisions in complex and rapidly changing environments.
- You have a proven track record of driving quality system improvements, compliance initiatives, inspection readiness programs, and operational excellence initiatives.
- You are skilled in organizational leadership, resource planning, budget management, and prioritization across multiple programs and competing business needs.
- You foster accountability, collaboration, and continuous improvement while creating an environment that encourages innovation and employee development.
- You communicate with clarity, credibility, and influence at all levels of the organization, including senior leadership and external regulatory agencies.
- You leverage data, quality metrics, and risk-based decision-making to drive business outcomes and improve organizational effectiveness.
What you'll get: - A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
- 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.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required: Experience and Education Requirements:- 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
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Salary:
$141,800.00 - $236,400.00
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