Director, QA - Product Development Processes

RXinsider LTD.; Northern, San Diego (KY, CA); Hybrid; USD 164,000 - 274,000; Full time

Benefits offered by this job

CGM technology impact

Benefits program

Global growth opportunities

Career development

Innovative organization

Job summary

Dexcom is seeking a global leader to own Design Control and Risk Management quality system processes across the product lifecycle. You will drive end-to-end traceability, lead training, and collaborate with cross-functional teams for regulatory readiness.

This senior role requires 13+ years in medical device development and 8+ years in leadership, with an engineering background. You’ll promote cross-functional quality standards, engage in audits, and guide the organization through CAPA and

Qualifications

• Global Design Control process leadership experience.
• Global Risk Management process leadership (ISO 14971 and IEC 60812).
• Risk Management integrated into Quality Management Systems (FDA QMSR and ISO 13485).

Responsibilities

• Owns design control and risk management procedures across product lifecycle.
• Develops training programs and drives continuous improvement.
• Represents Design Control and Risk Management during regulatory audits.

Skills

Design Control

Risk Management

Regulatory Inspections

Leadership

Education

Bachelor’s degree in a technical discipline

Engineering degree preferred

Tools

Quality Management IT systems

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 Design Quality Engineering (DQE) team at Dexcom is made up of incredibly passionate, collaborative, motivated, and competent people that think big, serve with integrity, and follow through on their commitments without fail. This team takes ownership in driving Design for Excellence (DfX) methodologies across the product lifecycle of Dexcom's on market products and future innovations, as well as leading strategies and supporting outcomes across our Design Control, Software Development Lifecycle (SDLC), Design Transfer, and Risk Management quality system processes.

Where You Come In

• You will be the accountable global process owner for Dexcom's Design Control and Risk Management quality system processes. This includes:
• Ownership of all Design Control and Risk Management procedures, instructions, templates, and tools in all lifecycle phases of Dexcom products that ensure complete end-to-end traceability.
• Proactively improve processes with state-of-the-art standards, regulations, and organizational feedback.
• Engaging directly in industry-wide initiatives around Medical Device standards and guidance.
• Responsibility for process mapping within and to adjacent processes of quality system.
• Developing and driving training program for the organization that ensures confident execution.
• Measurement of process effectiveness over time in Quality Management Reviews.
• Acting as strategy SME for complex situations within processes on project teams/specific issues.
• You will act as the Quality lead for Design Control and Risk Management Process Activities driven through continuous improvement, CAPA, or Quality Improvement Plans at Dexcom.
• You will be responsible for leading, organizing, developing, and growing an organization of site Business Process Owners.
• You and your team will be responsible for representing Design Control and Risk Management during regulatory audits and inquiries alongside work product authors.
• You will promote cross-functional understanding and adherence to quality standards, quality processes, and regulatory requirements.

What Makes You Successful

• Global Design Control process strategic leadership experience
• Global Risk Management process strategic leadership experience (ISO 14971 and IEC 60812)
• Risk Management integration into Quality Management Systems experience (FDA QMSR and ISO 13485)
• Experience implementing enterprise Design Control and Risk Management IT systems
• Value Stream Mapping and Business Process Mapping expertise
• Instructor-led training expertise
• Corrective and Preventive Action (CAPA) expertise
• Regulatory Inspections and Audits expertise
• People leadership, team development, and organizational design experience
• You must have a minimum of 13 years of experience in medical device development.
• You bring at least 8 years in progressively responsible leadership roles.
• You demonstrate an ability to adapt to shifting priorities and manage multiple initiatives.
• You possess exceptional interpersonal, written, and verbal communication skills.
• You are self-motivated with a collaborative, proactive, and accountable approach.
• Engineering degree preferred.

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 15+ years of industry experience
• Requires a degree in a technical discipline
• 9+ years of successful management experience in relevant industry

Flex Workplace:

Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). 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].

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

AI in Hiring Notice:

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

Salary

$164,200.00 - $273,600.00

#DexcomUS