Sr. Software Quality & Compliance Engineer
Personalis, Incabout 11 hours ago
Fremont, CA, USASenior / Mid Level
H1B Sponsor
Base Salary
$130k - $155k/yr
Responsibilities
- Drive the end-to-end GAMP 5 validation lifecycle for software and cloud platforms.
- Enforce regulatory alignment across software development activities.
- Spearhead proactive Risk Assessments to identify software hazards.
- Integrate AI-driven tools into the Quality Management System.
- Collaborate with IT to maintain a secure digital infrastructure.
- Serve as the primary SW Quality Subject Matter Expert during audits.
- Drive continuous improvement in eQMS configuration and workflows.
- Partner with Software Development and SQA teams for design control documentation.
Requirements
- BS in computer science or related field or equivalent experience.
- 5-8 years of experience in Software Quality Assurance or Compliance in a regulated industry.
- Proven track record of validating complex software systems.
- Hands-on experience with eQMS platforms like MasterControl or Veeva.
- Deep expertise in SDLC methodologies and core quality resolutions.
- Strong working knowledge of AI/ML principles and compliance.
Benefits
- Competitive compensation package including performance-based bonuses.
- Comprehensive medical, dental, and vision benefits.
- 401(k) match and Employee Stock Purchase Plan (ESPP).
- Tuition reimbursement and wellness benefits.
- Onsite gym and commuter benefits including EV charging stations.