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:
Our Quality organization is at the heart of everything we do. We are a collaborative, mission‑driven team committed to ensuring that every device we bring to market is safe, effective, and meets the highest standards of regulatory compliance. As part of the Quality Assurance (QA) Team, you’ll join a diverse group of professionals who work cross‑functionally with Engineering, Supply Chain, and Operations to uphold our commitment to patient safety and product excellence. We work closely with teams across the company to support design controls, validation activities, CAPA management, supplier quality, and product lifecycle initiatives while keeping focus on producing high quality product for our patients. We believe quality is everyone’s responsibility—and we lead by example.
Where you come in:
You will provide technical support for the projects, functions, and strategic objectives of Manufacturing Quality. You will be responsible for Supporting (via team) Materials manufacturing (i.e., Dexthane, DL Copolymer and Drug Formulation), Analytical Lab and strengthen cross-site alignment.
You will be responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality, and special controls for iCGM (Continuous Glucose Monitor) regulatory requirements.
You will perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
You will assure compliance to in-house and external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma). Provide guidance on NCMR dispositions and investigations and guidance on the CAPAs.
You will design methods and procedures for inspecting, testing, and evaluating the precision and accuracy of sensor manufacturing processes, Chemical Preparation, production equipment, and finished products.
You will manage a team of Quality Engineers supporting Sensor Manufacturing processes and production line.
What makes you successful:
You will have knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality Management Systems).
You will be able to organize and prioritize assignments providing direction to and participation in assigned functional teams.
You will have technical writing skills as applied to quality and manufacturing documentation and process development – Experience in creating and revising technical documentation.
You have the ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things with a proven track record of working hands-on in a fast-paced environment.
You can use analytical tools (5 Whys, fishbone, FMEA, DOE) to make clear, defensible decisions using risk‑based methodology that balances patient safety, compliance, and business needs.
You can lead root cause analyses with crossfunctional teams and assist your team with writing high-quality investigations, drive containment, corrective, and preventive actions and ensure timely closure of quality records.
You are a leader who can influence without authority, coach teams through compliance and improvement, encourage accountability and integrity and empower employees to reach their full professional potential.
Optional – Certification from the American Society for Quality (ASQ) for Quality Engineering, Reliability Engineering, or Certified Quality Manager/Organizational Excellence is preferred.
Optional – Familiar with experimental design, data analysis, and interpretation of experiments.
Optional – Lean Six Sigma Certification
certifications, specific industry experience, knowledge of additional systems, etc.
What you’ll get: (this section should not be modified)
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:
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.
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:
$141,800.00 - $236,400.00