Sr QA Engineer- CAPA

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:

As a Sr QA Engineer your role will be responsible for executing and coordinating Corrective and Preventive Actions (CAPA) Health Hazard Assessments (HHA/HHE) Non-Conforming Events (NCE) support Internal and External Audits defining requirements and aiding in the development of analytic dashboards validating and deploying Quality Assurance data and information dashboards with focus on Manufacturing Controls Quality Management Systems and New Product Development. This position will interface with different cross functional groups (Operations Data Analytics Customer Advocacy Quality Engineering Software Engineering Software Test Regulatory Affairs and others). The Sr. Quality Engineer role provides Quality Assurance Engineering and Compliance expertise and technical support to Sustaining Quality Engineering and Quality Control teams to ensure they have the necessary information to make quality decisions facilitate compliance to Dexcoms Quality Management System and international regulation standards (e.g. 21 CFR Part; ISO 13485 ISO 14971).

Where you come in:

• Leads and Coordinates and ensures compliance to CAPA HHA and NCE systems. Provide guidance as necessary to ensure appropriate depth of investigation and corrective and/or preventive actions. Assess effectiveness of corrective and preventive actions. Prepare QA Review Board meetings agenda and minutes.
• Guides and maintains the CAPA process including investigation root cause analysis corrective and preventive actions and effectiveness verification to drive continuous improvement and prevent recurrence of quality issues.
• Ensure CAPA activities are completed thoroughly timely and with objective evidence.
• Facilitate and guide investigations follow rigorous sciencebased methodologies (e.g. 5 Why Fishbone Fault Tree Analysis DMAIC).
• Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Equipment Process Software and Test Method Validation Auditing Calibrations CAPA Customer complaint processing Document control Nonconforming materials Process controls Receiving inspection Training.
• Participates in internal audits supplier audits to ensure systems comply with requirements and are effective.
• Applies risk management validation sample size and external standards review and implementation activities.
• Reads writes and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
• Assumes and performs other duties as assigned.

What makes you successful:

• Direct experience with Quality Management Systems Nonconforming Material CAPA HHA/HHE Nonconforming Events Internal and External Audits.
• Experience in FDA audits
• Good understanding of QMS as applied to medical devices.
• Collaborative able to work effectively and lead diverse functional groups.
• Demonstrates good judgment in selecting methods and techniques for problem solving and obtaining solutions.
• Can work well alone normally receives little instruction on day-to-day work general instructions on new assignments.
• A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.
• Experience with Oracle Camstar IQVIA 1Factory EtQ Reliance Korber SQL Servers Power BI Tableau.
• Experience with statistical analysis and statistical analysis software packages like Minitab and Jump
• Certified Quality Engineer Certified Quality Auditor a plus.

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:

• 0-5%

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.

Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.

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.

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