What are the responsibilities and job description for the Validation & Verification (V&V) SME – Medical Devices position at Qualis1 Inc.?
🚨 Hiring: Validation & Verification (V&V) SME – Medical Devices 🚨
📍 Location: San Diego, CA (Onsite)
📅 Duration: 12 Months
We are actively seeking an experienced Validation & Verification (V&V) Subject Matter Expert (SME) to join a high-impact medical device validation program in San Diego, CA.
This opportunity is ideal for professionals with extensive experience in regulated medical device environments who can independently drive end-to-end validation activities with minimal supervision.
🔹 Key Responsibilities:
• Author, review, and execute V&V protocols (IQ/OQ/PQ, system validation, software validation, CSV)
• Manage complete protocol lifecycle including execution, reporting, defect tracking, and closure
• Ensure compliance with FDA regulations, ISO 13485, and 21 CFR Part 820 requirements
• Collaborate with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs
• Provide SME-level guidance on validation strategies and risk-based approaches
• Support audit readiness and regulatory inspection activities
🔹 Must-Have Skills:
✔ 8–12 years of V&V experience in the Medical Device industry
✔ Strong expertise in protocol writing, validation execution, and reporting
✔ Deep understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971
✔ Experience working independently in regulated environments
✔ Ability to manage multiple validation protocols simultaneously
🔹 Preferred Qualifications:
✔ Experience with complex medical systems (Imaging, Surgical Systems, Elita platform, etc.)
✔ Exposure to Computerized System Validation (CSV)
✔ Experience in large-scale validation programs (100 protocols)
✔ Strong documentation and audit readiness experience
✔ Familiarity with QMS tools such as TrackWise, Veeva, or ETQ
🔹 Desired Competencies:
• Leadership
• Stakeholder Management
• Strategic Thinking
• Problem Solving
• Communication Skills
• Time & Priority Management