To Discuss more about this job opportunity, please reach out to Anwesha Mohapatra (LinkedIn URL -Anwesha Mohapatra - Collabera | LinkedIn), email your updated resume at Email - anwesha.mohapatra@collabera.com. Thank you!

Pay Range: $45/hr to $50/hr

Job Title: Software Quality Engineer

Location: Pleasanton, CA 94588

Work Type: Onsite

Contract Duration: 12 Months with possible extension

Job Summary:

• Seeking a Software Quality Engineer to support software verification and validation activities within a regulated medical device environment.
• The role will focus on software quality, documentation, requirements traceability, risk management, and SDLC processes.
• The position will also support cybersecurity assessments, sustaining engineering, post release activities, audits, and quality system improvements.
• The ideal candidate will collaborate with cross functional teams to ensure compliance with applicable FDA, ISO 13485, and IEC 62304 requirements.
• Strong analytical, communication, teamwork, and independent working skills are required.

Key Responsibilities:

• Support software verification and validation activities including test protocols, test plans, and test reports.
• Support assessments of non product software and product cybersecurity activities in collaboration with cross functional teams.
• Review software and system documentation to ensure quality and regulatory compliance.
• Maintain requirements traceability and support software development lifecycle processes.
• Perform risk assessments including FMEA and hazard analysis and support issue resolution.
• Participate in sustaining engineering, post release support, design reviews, and quality approvals.
• Support post release changes, audits, and quality system improvement initiatives.
• Collaborate with engineering, quality, and other functional teams to support regulatory compliance.

Required Qualifications:

• Bachelor’s degree in Computer Science, Software Engineering, Systems Engineering, or a related technical field.
• Minimum 2 years of experience in software quality, validation, systems engineering, or a related discipline.
• Experience working in a regulated industry such as medical devices, diagnostics, or pharmaceuticals.
• Knowledge of software verification and validation processes, requirements traceability, risk assessment, and SDLC processes.
• Strong analytical, communication, teamwork, and independent working skills.

Preferred Qualifications:

• Experience supporting audits within a regulated environment.
• Experience with product cybersecurity assessments.
• Experience with FDA, ISO 13485, and IEC 62304 compliance activities.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)