Job Description
A client in the medical device space is seeking a Sr. Software Quality Assurance Engineer to join their organization for a 6-month contract to support 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, design validation, and post market activities. This resource will support software quality efforts across the product lifecycle, contributing to design controls, risk activities, and post-market support. They will also help ensure IEC 62304 compliance, assist with testing, and support NCP, CAPA, and complaint processes alongside cross-functional teams. 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 HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
• Bachelor’s degree in Computer Science, Engineering, or related field
• 3-5 years of experience in Software Quality related roles
o Well versed in risk assessment and testing processes/methodologies
• Experience in Medical Device industry or other highly regulated spaces
o Well versed with manual system-level testing in regulated environments
o Exposure to CAPA/Complaint handling or external audits
• Deep understanding of the SDLC per IEC 62304 and IEC 82304
o Knowledge of programming languages like C#, C++, Swift, Node.js, Java/JavaScript, Python, etc.
• Risk Management experience working with ISO 14971
Nice to Have Skills & Experience
• Advanced Degree in a related field
• Experience with Neuromodulation products
• Quality Engineering Certifications (CQE or CSQE)
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.