Job Title

Job Description A client in the medical device space is seeking a Sr. Software Quality Assurance Engineer to join their organization for a defined two-year term to backfill a team member assigned to internal projects. The ideal resource will be well versed in Quality SW principles within the medical device industry and have deep expertise in risk assessment, testing, and design validation. This resource should be detail oriented with strong documentation and able to identify risks and process improvements on their own to share with cross functional teams including R+D, Marketing, Regulatory, etc. This resourceu2019s time will be split up into 50% design validation activities, 30% SDLC work, and 20% risk management through testing. This role will be hybrid, onsite 3 days per week in Valencia, CA. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Skills and Requirements u2022u2003Bacheloru2019s degree in Computer Science, Engineering, or related field u2022u20035+ years of experience in Software Quality related roles ou2003Well versed in testing processes/methodologies and risk assessment u2022u2003Experience in Medical Device industry or other highly regulated spaces ou2003Well versed with manual system-level testing in regulated environments u2022u2003Deep understanding of the SDLC per IEC 62304 and IEC 82304 ou2003Knowledge of programming languages like C#, C++, Swift, Node.js, Java/Javascript, Python, etc. u2022u2003Risk Management experience working with ISO 14971 u2022u2003Advanced Degree in a related field u2022u2003Experience with Neuromodulation products u2022u2003Exposure to CAPA/Complaint handling or external audits u2022u2003Quality Engineering Certifications (CQE or CSQE)