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Sr QA EngineerDexcom Deutschland GmbHUnited States

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XX

Sr QA Engineer

Dexcom Deutschland GmbH
  • US
    United States
  • US
    United States

About

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 are just getting started. We are broadening our vision beyond diabetes to empower people to take control of health, delivering personalized, actionable insights that solve important health challenges. To continue what we've started: improving human health.
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 work as a QA engineer of the Product Development 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 develop processes and perform quality functions that help the company achieve its quality policy requirements and comply with regulations, including supporting Corrective Action Preventive Actions (CAPAs), Post‑Market Surveillance, Biocompatibility, Sterilization, Electrical Safety.
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 comply with domestic and international regulations.
Execute 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 waste in processes.
What Makes You Successful
You have knowledge in medical device design control – especially planning, inputs, verification, validation, change, risk management, but also biocompatibility/sterilization, electrical safety.
You are able to effectively adapt to new responsibilities, 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, EU MDR, 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 of technical procedures, international standards and government regulations will 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 bachelor’s degree in a technical discipline, and a minimum of 5–8 years related experience. A master’s degree and 2–5 years equivalent industry experience, or a PhD and 0–2 years experience, is also acceptable.
Flex Workplace Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120 km).
Salary $87,000.00 – $145,000.00
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.
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  • United States

Languages

  • English
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