Sr QA Engineer at Dexcom

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Feb, 26

Salary

145000.0

Posted On

19 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Device Design Control, Risk Management, Verification, Validation, Data Analysis, Collaboration, Compliance, Biocompatibility, Sterilization, Electrical Safety, Statistical Analysis, Technical Procedures, International Standards, Government Regulations

Industry

Medical Equipment Manufacturing

Description

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: 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 compliance 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, 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. 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/120km). 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 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. 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

Responsibilities

As a QA Engineer, you will assist with defining design inputs, verifying design outputs, and validating user needs. You will also develop processes to ensure compliance with quality standards and regulations.