Software Quality Sr Engineer
Zimmer Biomet25 days ago
Base Salary
$100k - $124k/yr
Responsibilities
- Review software requirements, designs, deliverables, test plans, validation protocols, traceability matrices, and validation reports for quality and regulatory compliance.
- Ensure adherence to quality-system processes, design controls, software lifecycle requirements, and end-to-end traceability between requirements, risk controls, and verification evidence.
- Develop and execute test plans, test cases, and validation protocols for verification and validation activities.
- Perform functional, integration, and system-level testing for embedded software and cloud-based systems.
- Participate in risk assessments, design reviews, code reviews, quality reviews, change-impact assessments, and defect investigations.
- Prepare validation and compliance documentation and support audit readiness and regulatory inspections.
Requirements
- Bachelor’s degree and 4 years of relevant experience or equivalent experience.
- Preferred bachelor’s degree in computer science, computer engineering, or a related field.
- Four or more years of software validation and quality experience in a regulated environment, preferably medical devices.
- Strong understanding of software verification and validation principles, test coverage, and objective evidence.
- Experience with validation deliverables, including test plans, validation protocols, execution reports, and traceability matrices.
- Familiarity with ISO 14971 risk management, change management, configuration management, version control, and release traceability.
- Knowledge of FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11.
- Experience working cross-functionally with R&D, QA, and Regulatory teams.
Benefits
- Onsite work five days per week in Austin, Texas.
- Up to 10% travel required.
- Flexible working environment, development opportunities, employee resource groups, wellness incentives, and recognition and performance awards.