: Sr. Software Quality Engineer – Design Control & Compliance needed for a contract opportunity with Yoh Scientific’s client located in San Jose, CA. This position is for a major in vitro diagnostics company and requires someone with demonstrated competence in software development processes, good practices, and ability to apply quality engineering tools and techniques. Shift: Hybrid setting, 3x a week in the office. Key Responsibilities

Support quality engineering for product software design control, including risk management planning, design reviews, and updating DHF. Lead risk management activities for R&D, including risk file updates and risk analysis. Serve as primary contact for R&D projects, providing coaching on development processes, design control, and risk assessment. Review and give feedback on design documentation. Participate in technical design reviews and change management processes. Assist in developing and reviewing quality management system procedures. Maintain compliance with quality systems and prepare for audits and inspections. Participate in CAPA activities, including investigations and root cause analysis.

Qualifications

Bachelor’s degree in a related science field. Minimum 8 years’ experience in a regulated industry. Proven competence in software development and quality tools. Experience with ISO 14971 risk management. Knowledge of relevant regulations and standards (ISO, QSR, IVDR, MDSAP). Effective communication skills. Proficiency in Microsoft Office. Certifications such as CQE, CQA, CSQE, CRE, BCA, or Six Sigma Black Belt preferred.

Opportunity is calling. Apply now! This is a 9-month contract with potential extension or conversion. Salary ranges from $52.15 to $74.50 per hour, depending on experience. Benefits include medical, dental, vision, 401K, life insurance, and more. Yoh offers a vast network of opportunities and is committed to diversity and inclusion. Note: Pay ranges are estimates; actual pay depends on experience and qualifications. Yoh is an Equal Opportunity Employer. For accommodations, visit https://www.yoh.com/applicants. #J-18808-Ljbffr