Sr QA Engineer

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: 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 in global 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 define, support, and improve the processes that get us there. Where you come in: You actively participate as a core team member for new manufacturing automation equipment development teams. Duties include providing technical team regulatory guidance, ensure adherence to Quality Management System, help define equipment requirements, aid with process development, develop risk assessment, participate in concept and design reviews, develop equipment qualification and process validation strategy, support equipment buyoff activities at vendor site(s), support Process Validation activities at Dexcom manufacturing site(s), demonstrate product/process specifications are met and maintained. You act as subject matter expert to help develop and support equipment qualification and process validation (SW validation, IQ, TMV, OQ, PQ, process monitoring) activities. You support new manufacturing process development and provide sustaining quality engineering support during initial commercial implementation of a new process. Duties include assisting root cause investigation, initiation and disposition of nonconforming materials with the Materials Review Board, equipment and process improvement changes. You lead multi-level, cross-functional, and international cross-site alignment on complex topics and provide direction with strong critical thinking. You improve over time and ensure continued adherence to Quality Management System and risk management procedures to help Dexcom maintain its quality policy and compliance with domestic and international regulations. You participate in internal audits and audits done by external regulatory bodies to ensure quality management system complies with regulatory requirements. What makes you successful: You have experience and application of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems). You are proficient with reading, writing, and reviewing extensive technical documentation, drawings, and specifications. Your proficient with root cause analysis, six sigma, structured problem solving, test method validation, software validation, process validation, process capability measurement (Cpk), lean manufacturing, sampling plans and statistical analysis. You have computer and data analysis skills in the use of Microsoft Office and other applications e.g. Excel, JMP, MiniTab. You have excellent communication (written and oral, read/write/interpret) skills. You can organize and prioritize assignments providing direction to and participation in assigned cross functional teams. You bring initiative and integrity to drive identification, assessment, and corrections for compliance and procedural gaps. You can work in a dynamic work environment and perform other duties as assigned. What youll 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 Bachelors degree in a technical discipline, and a minimum of 5-8 years related experience or Masters degree and 2-5 years equivalent industry experience or a PhD and 0-2 years 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. Dexcoms 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 Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.