Software QA Engineer 2

Regulatory Toolkit; United States; Remote; USD 79,000 - 132,000; Full time

Job summary

Dexcom Corporation seeks a Software Quality Assurance Engineer to support regulatory compliance and software validation across cross-functional teams. You will guide IEC 62304, 21 CFR 820, ISO 14971 and other regulations, drive risk management deliverables, and review technical documentation.

This role partners with Software Design and Test, supports post-market activities, communicates plans and status to management in a fast-paced environment, and requires a technical bachelor’s with 2–5 years

Qualifications

• Experience with software mobile applications is required.
• Regulatory compliance experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971 is preferred.
• Strong SDLC knowledge and methodologies (Agile/Waterfall).

Responsibilities

• Participate as a core team member of the R&D Quality Assurance Engineering team.
• Provide guidance on IEC 62304, 21 CFR 820, ISO 14971 and related regulations worldwide to cross-functional teams.
• Lead in the application, compliance and improvement of policies, procedures and practices for software development and validation across software teams.
• Provide technical guidance on equipment, software, product, process requirements and risk management deliverables (SHA, FMEA).
• Guide Software Design and Test Teams for system validations, design verification, traceability, CM, tool validations and integrations.
• Support post-market activities related to software anomalies, risk assessments and CAPA.
• Review, author, revise and approve technical documentation (DHF, SOPs, protocols, reports).
• Assess impact of change control to maintain compliance.
• Communicate with Dexcom team and upper management on plans and progress.

Skills

Mobile software

Software QA

Requirements analysis

Product integration

Software testing

Cyber security

CSQE certification

Jama

Jira

TestRail

Education

Bachelor's degree in a technical discipline

Master's degree (optional)

Tools

Jama

Jira

TestRail

Kettryx

Job 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:

This functional department provides technical support and guidance to the Software teams to ensure conformance to software development process and applicable safety and quality system regulation and standards such as IEC 62304, ISO 13485, ISO 14971, 21 CFR 820. Weare responsible forvarious aspects of Software Design Assurance withfocuson product improvement, new productdevelopmentand defect prevention. Weinterface withdifferent cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project management, System Engineering, Clinical and others). This team hasa great teamculturebysupporting each other in a fast-paced environment and dealing with shifting priorities with a positive attitude.

Where you come in:

• You will activelyparticipateas a core team member of the R&D Quality Assurance Engineering team
• You will provide guidance on IEC 62304, 21 CFR 820,ISO14971and other relevant regulations worldwide to the cross-functional teams
• You will lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams
• You willprovidetechnical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA,designand process FMEA
• You will provide guidance to Software Design and Test Teams for System validations, Software design verification and traceability, Software configuration management, tool vali‑dations and software integrations.
• You will support post market activities related to Software anomalies, riskassessmentsand CAPA activities (if applicable)
• Youare responsible forreviewing, authoring, revising, and approvingappropriate technicaldocumentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables
• You will assess impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained
• You will effectively communicate with broad Dexcom team and upper-level management on plans, status of tasks, projectprogressand challenges
• You will assume and perform other duties as assigned

What makes you successful:

• You have experience working with software mobile applications
• You bring Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO13485and ISO 14971
• Your knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model
• Your Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
• Yourproficiencyto interpret software design and code to verify implementation of requirements
• You have Software development and/or Software test experience.
• Your ability to understand complex tasks and goals.Drive projects to completion with limited supervision.
• Your ability to communicate and present to all levels of management
• Nice to haveknowledge ofCyber Security
• Nice to have ASQ Certified Software Quality Engineer (CSQE) certificationor equivalent
• Nice to have Jama, Jira,Kettryx,and/orTest Railsexperience

Whatyou’llget:

• A front row seat tolife changingCGM technology. Learn about our brave #dexcomwarriors community.
• Afull andcomprehensive benefitsprogram.
• Growth opportunities on a global scale.
• Access tocareer development through in-house learning programs and/orqualifiedtuition reimbursement.
• Anexcitingandinnovative,industry-leading organizationcommitted to our employees,customers, and the communities we serve.

Travel Required:

• 0-5%

Experience and Education Requirements:

• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2 - 5 years related experience or Master's degree and 0-2 years' equivalent 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 [e-mail].

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 [e-mail].

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

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Salary: $78,900.00 - $131,500.00

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