Senior Staff Quality Engineer
San Diego, CA - USA
Job Summary
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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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:
Join us in empowering people to take control of their health! You will join a collaborative team at the heart of Dexcoms products. Our quality engineering team plays a crucial role inglobalcross-site and cross-functional alignment for the future of Dexcom and for the future of our customers health.
As the Senior Staff QA Engineer you will support Dexcom in bringingstate-of-the-artinnovative technology to patients and will help define support and improve the processes that get us there.
Where you come in:
Serves as a Sr Staff Quality Engineer responsible for driving quality compliance and inspection readiness across products processes and systems. This role partners cross-functionally to ensure the organization maintains a continuous state of audit readiness proactively identifies compliance risks and implements scalable sustainable quality solutions.
Drive inspection readiness programs including mock audits readiness. assessments and documentation preparedness.
Establish and monitor audit readiness metrics.
Implement proactive strategies to prevent repeat findings and improve overall quality system effectiveness.
Influence stakeholders at all levels to drive consistent execution of quality and compliance processes.
Mentor engineers and provide guidance on compliance best practices and audit preparedness.
You lead complex investigations and drive systemic improvements
You proactivelyidentifysystemic compliance or procedural gaps across programs or processes and lead the teams that develop and implement corrective and preventive actions with cross functional buyin.
Participate in internal audits and external regulatory inspections.
You ensure adherence to design control requirements across products processes and systems.
What makes you successful:
You have hands-on experience with FDA 21 CFR 820 ISO 13485 and related Quality Management System requirements and you can interpret and apply them at a system and program level.
In-depth understanding of Quality Compliance and Regulatory Compliance frameworks in a medical device environment.
Youare proficientat reviewing and interpreting complex technical documentation engineering drawings and specifications and you can guide others in doing the same.
You have strongproficiencyin data analysis tools such as Excel and JMP and can guide teams in developing robust data driven decisions.
You communicate with clarity and influence across all levels of the organization ensuring alignment with engineering operations leadership and global partners.
You formulate and drive implementation of comprehensive cross functional quality solutions gaining alignment across stakeholders and global sites.
You independently organize prioritize and lead strategic initiatives while serving as a key contributor on cross functional teams.
You consistentlydemonstrateinitiative ownership and integrity in driving high impact quality and compliance improvements.
You thrive in a dynamic environment and support the broader quality andoperationsorganizations as needed.
Whatyoullget:
A front row seat tolife changingCGM technology.Learn about our brave #dexcomwarriors community.
Afull andcomprehensive benefitsprogram.
Growth opportunities on a global scale.
Access tocareer development through in-house learning programs and/orqualifiedtuition reimbursement.
Anexcitingandinnovativeindustry-leading organizationcommitted to our employeescustomers and the communities we serve.
Travel Required:
5-15%
Education and Experience:
Typically requires a Bachelorsdegree in a technical discipline anda minimum of 13 years relatedexperience or a Masters degree and8 years equivalent industryexperience or a PhD and 5 years ofexperience.
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. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at
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
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: 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:
$128600.00 - $214400.00Required Experience:
Staff IC
About Company
Dexcom Continuous Glucose Monitoring is simplifying diabetes management with a small device, accurate real-time glucose readings, and proven results. No fingersticks or scanning.â€