Software Quality Engineer II
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
We advance science so that we all have more time with the people we love.
Roche is the world’s #1 provider of companion diagnostics, offering unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.
The Software Quality Engineer (Engineer) will have expertise in software verification & validation; quality assurance, continuous improvement "best practices" along with strong documentation and reporting skills. The Engineer will have proficiency working with motherboards, reimaging systems, and Microsoft Windows operating systems. In addition, the engineer will have excellent analytical and problem-solving skills, demonstrating a strong attention to detail and ability to work both independently and as part of a team.
You will design, develop, and execute test plans, test cases, and test scripts for software applications and systems.
You will perform functional, regression, integration, and system testing to ensure software meets defined requirements.
You will document and track software defects, working closely with the development team to ensure timely resolution.
You will participate in the development and review of software requirements and specifications to ensure they are testable and complete.
You will perform risk assessments and contribute to the creation of risk management documentation as required by regulatory standards.
You will ensure that software development processes and deliverables comply with company quality standards and regulatory requirements (e.g., FDA, ISO 13485).
You will identify opportunities for process improvements and contribute to the development of best practices in software quality engineering.
You will stay updated on industry trends and advancements in software testing and quality assurance methodologies.
You will prepare and maintain detailed documentation for testing procedures, defect reports, and test results; provide regular status updates and reports on software quality metrics and testing progress to stakeholders.
Who You Are:
(Required)
You have a Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, or a related field and experience in software quality assurance or software testing in the medical device and/or healthcare industry.
You have 2 - 5 years of experience in software testing within FDA regulated environments; a demonstrated level of experience with FDA regulations (21 CFR Part 11, Part 820) and ISO standards (e.g., ISO 13485, IEC 62304) related to software testing for medical devices.
You have a demonstrated level of experience developing and reviewing verification reports and compliance documentation; you have the ability to independently write detailed software verification reports for regulatory compliance, maintaining thorough traceability.
You have demonstrated experience with quality management systems (QMS) and electronic documentation systems.
You have a strong understanding of software development lifecycle (SDLC) and software testing methodologies.
Preferred:
You are highly organized and have effective communication skills, both written and verbal.
You have experience working in the medical device / diagnostics space.
WORK ENVIRONMENT
The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, bloodborne pathogens, and automated equipment. While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.
This role is on-site in Carlsbad, CA and Torrey Pines, CA.
There are no relocation benefits for this role.
The expected salary range for this position based on the primary location of Carlsbad, CA is $77,000 - $143,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.
Who we are
GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.
GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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