This role involves conducting technical audits across the software development lifecycle, assessing adherence to quality management systems, and supporting continuous improvement initiatives for product software including SAMD, SIMD, Non product software and cloud based applications
Job Summary
This role involves conducting technical audits across the software development lifecycle, assessing adherence to quality management systems, and supporting continuous improvement initiatives for product software including SAMD, SIMD, Non product software and cloud based applications.
The position is responsible for ensuring executive management is aware of compliance business risks and regulatory requirements.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
Matching Summary
This role involves conducting technical audits across the software development lifecycle, assessing adherence to quality management systems, and supporting continuous improvement initiatives for product software including SAMD, SIMD, Non product software and cloud based applications.
Salary
Base: $129,300.00 – $258,700.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement, student debt program, education benefit
Skills & Requirements
Must-have
medical device software auditing
software development lifecycle audits
quality management systems assessment
regulatory compliance
risk management files review
FDA 21 CFR Part 820
IEC 62304
Nice-to-have
continuous learning and improvement
cross-divisional integration
executive management communication
best-practice analysis tools
Key Requirements
Four-year degree in scientific, technical or compliance discipline or equivalent experience
Lead auditor certificate for Quality System audits desirable
10+ years in software design and development in medical device industry
Experience with GxP principles desirable
Experience with product submissions or regulatory audits desirable