Sr QA Engineer

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 A great opportunity with a face paced and steadily growing organization; that is new enough to be exciting and full of opportunity and mature enough to have resources and infrastructure. The opportunity to transform the lives of diabetics is exceptionally rewarding.Where You Come In

• You Developprocesses and performquality functions that help the company achieve its quality policy requirements and comply with regulations, including supporting Corrective Action Preventive Actions (CAPAs), Post Market Surveillance, manufacturing operations
• You Work as the QA Core Team Lead of the Design Team within the R&D Department, and assist with defining design inputs, designing components and processes, verifying that design outputs satisfy design inputs, and validating user needs are met.
• You perform analysis of reports and data to identify trends, and recommend updates or changes to quality standards and procedures when necessary.
• You ensure compliance to external specifications and standards.
• Develop company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
• Lead risk management, validation, sample size, and external standards review and implementation activities.
• Develop systems and processes that improve product safety, improve process efficiency, increase product consistency and conformance to requirements, and reduce wasteful processes.

What Makes You Successful

• You have knowledge in medical device design control – especially planning, outputs, verification, validation, change, transfer, risk management
• You are able to effectively adapt to changes in projects, processes, and industry
• Your experience writing in the medical device or related industry will be extremely valuable to demonstrate compliance to CFR, EUMRD, ISO 13485 and related standards, regulations, and guidance.
• Your collaboration and influence through verbal and written means will be an asset
• Your ability to analyze data through statistical means
• Your analysis and interpretation technical procedures, international standards and government regulations, to assure safety, high performing products, and compliance

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.

Experience and Education

• 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. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at 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 the OFCCP's Pay Transparency Non Discrimination Provision at this link .UnitedHealthcare 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 $82,900.00 - $138,100.00

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