The company is seeking a Senior Software Quality Engineer to ensure software development aligns with key regulatory standards and bridge the transition from a startup research environment to a fully FDA-compliant development and manufacturing organization.
Requirements
- Experience at an IVD company or in Software as a Medical Device (SaMD)
- Demonstrated experience supporting products from concept through market release
- Strong knowledge of FDA and international software regulations, with hands-on audit preparation experience
- Understanding of cybersecurity concerns in regulated medical software
- Proficiency with quality tools and risk management frameworks (e.g., 8D, Ishikawa, FMEA)
- Knowledge of 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971
- Preferred: ASQC Certification, or Lead Auditor Certification
Responsibilities
- Developing release readiness checklists and implementation plans for deploying new software releases
- Review and enhance risk assessments (e.g., FMEA, hazard analysis) and test plans for software and hardware systems
- Update traceability matrices, collaborate in requirements definition, and initiate a Master Validation Plan
- Lead the creation of detailed design documents capturing the implementation of software requirements
- Support development and implementation of software-related change control and design change procedures
- Lead test strategy development and execution for unit, integration, and system-level testing
- Mentor junior quality engineers and foster a culture of compliance and continuous improvement
Other
- B.S. in a technical, software, or life sciences discipline
- 6–9 years in a quality role within a regulated biotech or medtech company
- Build consensus across technical and regulatory teams
- Are proactive, adaptable, and solution-oriented
- Thrive in complex, regulated environments where innovation is key
- Communicate clearly and confidently, especially in technical writing
- Have a passion for quality, problem-solving, and protecting patient safety
