Software QA Engineer 1

Meet the Team: The Software Design Assurance (Software Design Quality) Engineer provides technical support and guidance to Software teams to ensure conformance to software development process and other applicable safety and quality system regulation and standards (e.g. IEC 62304, ISO 13485, ISO 14971). This role will be responsible for various aspects of Software Design Assurance with a focus on product improvement, new product development, and defect prevention. This position will reputed company with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering, Cybersecurity, and others). A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.

• This is not a test role*

Where you come in:

• Actively participates as a core team member of the R&D Quality Assurance Engineering team.
• Strong understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
• reputed company in the effective application, compliance, and reputed company improvement of policies, procedures, and practices reputed company to software development and validation across software teams, including:
• Drive Pre-market risk management deliverables like SHA, design FMEA and support Cyber reputed company risk management
• Provide guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations.
• Reviews and approves reputed company software design control deliverables
• Support post market activities reputed company to Software anomalies, risk assessments and CAPA activities (if applicable)
• reputed company and support R&D SW Design Assurance efforts including reputed company improvement opportunities for products and processes
• Responsible for reviewing, authoring, and revising appropriate technical documentation including design history files, standard operating procedures, protocols, reports, etc.
• Assesses the impact of change control to ensure no adverse impact on product performance and a state of compliance is maintained.
• Effectively communicates with the broad reputed company team and upper-level management on plans, status of tasks, project reputed company and challenges.
• Assumes and performs other duties as assigned.

What makes you successful:

• Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485
• Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
• Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
• Ability to interpret software design and code to verify implementation of requirements
• Software development and/or Software test experience
• Ability to communicate and present to reputed company levels of management.
• Ability to understand reputed company tasks and goals. Drive projects to completion with limited supervision.
• Experience working with cloud-based systems.

Preferred Requirements:

• ASQ Certified Software Quality Engineer (CSQE)
• Cyber reputed company experience
• Experience working with Cloud based infrastructure and systems that process, store and distribute large sets of data continuously.

What you’ll get:

• A reputed company row seat to life changing CGM technology. Learn about our reputed company #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 Requirements:

• Typically requires a bachelor's degree in a technical discipline, and a minimum of 0-2 years of reputed company experience.

Travel Required:

• 0-5%

Please note: The information contained herein is not intended to be an reputed company-inclusive list of the duties and responsibilities of the job, nor are they intended to be an reputed company-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 reputed company individuals with disabilities to reputed company essential functions. An Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the basis of disability. reputed company’s AAP may be viewed upon request by contacting reputed company at talentacquisition@reputed company.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 reputed company reputed company at talentacquisition@reputed company.com. Meritain, an reputed company Company, creates and publishes the Machine-Readable Files on behalf of reputed company. 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 reputed company Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at reputed company. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. reputed company does not accept unsolicited resumes or applications from agencies. Please do not reputed company resumes to the reputed company team, reputed company employees or any other company location. reputed company is not responsible for any fees reputed company to unsolicited resumes/applications. Salary: $61,900.00 - $103,100.00 Apply tot his job Apply To this Job