QA Engineer 2

San Diego, CA, United States

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

Meet The Team

Join us in empowering people to take control of their health! You will join a collaborative team at the heart of Dexcom’s products. Our quality engineering team plays a crucial role in cross-site and cross-functional alignment for the future of Dexcom and for the future of our customers’ health. You will support Dexcom in bringing state-of-the-art innovative technology to patients and will help to define, support, and improve the processes that get us there. A positive and team-oriented attitude is important while working in a fast-paced environment and dealing with shifting priorities.

Where You Come In

You offer expertise in root cause analysis for nonconformance's and issues that arise during qualification activities and commercial manufacturing.

You apply your hands-on experience with high volume manufacturing in medical device, biosensor, or regulated industry and support review and revision of technical documentation including process instructions, standard operating procedures, protocols, reports, etc.

You provide leadership and technical guidance to support creation of/improvement to Quality Management System practices, qualification and validation requirements, CAPAs, NCMRs, Process Controls.

You lead multi-level, cross-functional, and international cross-site alignment on complex scientific topics and provide direction with strong communication (written and oral) and excellent inter-personal skills.

You oversee area audit readiness, implementing tools where necessary to support and strengthen.

You assess the impact of change control to qualified systems to ensure a state of compliance is maintained.

You take the initiative and have the drive to develop systems and processes that improve product safety and increase product consistency and conformance to requirements.

You provide technical guidance with respect to equipment, software, product, and process requirements including defining, identifying, and revising failure mode effects and analysis (FMEA).

What Makes You Successful

Your Chemical Engineering or similar degree from accredited College/University.

Your Six Sigma, Lean manufacturing, and/or sustaining experience to support operations and process definition and improvements.

Your proficiency with statistical data analysis, sample size requirements, sampling plans, AQL, confidence intervals, etc.; JMP experience preferred.

Your competency in Root Cause Analysis and Structured Problem Solving to support quality investigations.

Your familiarity with Medical Device or regulated industry requirements, e.g. FDA 21 CFR 820, 21 CFR Part 11, 21 CFR Part 4, ISO 13485, EU MDR.

Your experience with and ability to apply effective risk management and/or risk-based quality guidance for validation, sample size, and external standards review and implementation activities.

Your initiative and drive to balance independent work with program alignment.

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

0-5%

Experience And Education Requirements

Typically requires a Bachelor’s degree and a minimum of 2-5 years of related 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 [email protected].

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 [email protected].

View the OFCCP's Pay Transparency Non Discrimination Provision at this link .

UnitedHealthcare 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://transparency-in-coverage.uhc.com/.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

Salary

$68,200.00 - $113,600.00

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