Sr QA Engineer at Dexcom, Inc in San Diego, California

Job Description:

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 apply expertise in root cause analysis, six sigma, structured problem solving, Test Method Validation (including but not limited to Gage R&R), process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics.


• You lead complex NCMRs/CAPAs and the creation of/improvement to the Quality Management System, qualification/validation requirements, SOPs, process controls, and FMEAs.


• You champion multi-level, cross-functional, and international cross-site alignment on complex scientific issues and provide direction with strong communication (written and oral) and excellent interpersonal skills. You partner with R&D, Regulatory Affairs, Customer Advocacy, Process Engineering, Manufacturing, Equipment Engineering, Maintenance teams and more.


• You drive identification, assessment, and corrections for compliance and procedural gaps.


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


• You assess and manage the impact of change control to products, qualified systems, SW, and validated processes to ensure product safety and compliance.


• You take the initiative to develop systems and processes that improve product safety, increase product consistency, improve product efficiency, reduce operating and scrap costs, and maintain conformance.

What makes you successful:

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


• Your familiarity with Pharmaceutical and/or Combination Product requirements, e.g. 21 CFR 4, 11, and 820, USP, ISO 13485, EU MDR.


• Your hands-on experience with risk management and risk-based decision-making in high volume manufacturing in pharmaceutical, combination product, medical device, and/or biosensor industries.


• Your proficiency with quality engineering tools including statistical data analysis, sample size requirements, sampling plans, AQL, confidence intervals, etc.; JMP experience and six sigma certification(s) preferred.


• Your experience with chemistry, polymers, and complex analytical methods as they relate to manufacturing and material/process characterization.


• Your interest in being "hands-on" and on the manufacturing floor to learn new technologies/processes, assess risk, and troubleshoot.


• Your competency in assessing and documenting risk during various phases of design controls and in providing solutions to address risk while moving new products and processes to commercialization.


• Your agility to balance independent work with program alignment, implementing efficient and effective communications and problem solving cross-functionally with both small and large groups.

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 5 - 8 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 talentacquisition@dexcom.com.


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 talentacquisition@dexcom.com.


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


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


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:
$87,000.00 - $145,000.00 Apply Now