Sr Manager QA Engineering

1 DexCom Inc; San Diego (CA); On-site; USD 142,000 - 236,000; Full time

Benefits offered by this job

Comprehensive benefits program

Global growth opportunities

Career development programs

Job summary

Dexcom is seeking a Senior Manager, QA Engineering to lead a team responsible for high-volume manufacturing automation equipment, product introductions, and process validation. You will drive quality, compliance, and risk management across programs and sites.

You will establish strategic direction for quality activities, ensuring alignment with regulatory requirements and business goals, while mentoring teams and partnering with Engineering, Operations, and R&D to deploy advanced manufacturing

Qualifications

• Experience leading Quality Engineering teams in a regulated environment.
• Deep knowledge of FDA 21 CFR 820, ISO 13485, Design Controls, Process Validation, Risk Management, and QMS.

Responsibilities

• Lead a team of Quality Engineers supporting high-volume manufacturing automation equipment.
• Oversee Design Control, Design Transfer, Process Validation, and Manufacturing Quality activities.
• Ensure compliance with regulatory requirements and prepare for inspections and audits.
• Drive continuous improvement through quality metrics, CAPA effectiveness, and systemic problem-solving.

Skills

Leadership

Quality Engineering

Regulatory Compliance

Process Validation

Risk Management

Quality Metrics

CAPA

Cross-functional Collaboration

Data-driven Decision Making

Education

Bachelor’s degree in a technical discipline

Job description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

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:

5-15%

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.

An Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail].

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [e-mail].

Salary:

$141,800.00 - $236,400.00 #DexcomUS

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.