Sr. Bioinformatics Quality/Test Engineer
La Jolla - 11085 N Torrey Pines Rd, United States
USD 131K-182K Senior-level Full Time
Tasks
- Create software verification and validation documentation
- Develop test strategy and test plans
- Execute IQ, OQ, PQ protocols
- Lead verification and validation testing
- Manage design controls for medical device software
- Mentor team on software quality processes
- Perform software risk assessments and traceability
- Plan and manage software release testing
- Support audits and respond to audit queries
- Test bioinformatics pipeline product functionality
- Translate requirements into verification and validation protocols
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | AWS | Agile | Azure | CFR Part 11 | CI/CD | Cloud platform | Code review | DOORS | Design Controls | Docker | Git | Google Cloud | Google Cloud Platform | GxP | Hazard Analysis | IBM DOORS | IEC 62304 | ISO 13485 | ISO 14971 | ISO 9001 | Integration Testing | Jama | Kubernetes | Management System | Next-Generation Sequencing | PCR | Part 11 | Python | Quality Management System | Quality management | RM tool | Requirements Management | Risk Assessment | System Testing | Test automation | Traceability matrix | Unit Testing | Verification and Validation
Education
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