Validation & Verification (V&V)

Role: Validation & Verification (V&V)Location: San Diego,CAJob Description: Role Descriptions: Must Have Technical/Functional Skills Must-Have Skills · Strong expertise in V&V for medical devices · Hands-on experience in: o Protocol writing (IQ, OQ, PQ, CSV, system validation) o Validation execution and reporting · Deep understanding of: o FDA regulations (21 CFR Part 820) o ISO 13485 standards o Risk management (ISO 14971) · Experience in regulated environments with minimal supervision · Ability to independently manage multiple protocols simultaneously Preferred Skills · Experience with complex medical systems (e.g., imaging systems, surgical systems, or similar platforms like Elita) · Exposure to software validation / computerized system validation (CSV) · Prior experience in large-scale validation programs (100+ protocols) · Strong documentation and audit readiness experience · Familiarity with tools like: o TrackWise / Veeva / ETQ (or similar QMS systems) Experience Requirement · 8–12+ years in V&V within the medical device industry · Proven experience working as a Subject Matter Expert (SME) · Prior experience working in onsite client environments in the US is a strong plus · Expat profiles are acceptable Candidate Profile · Self-driven and capable of working independently with minimal guidance · Strong ownership mindset with execution focus · Excellent communication and stakeholder management skills · Comfortable working under tight timelines and immediate onboarding expectations Roles & Responsibilities Role Overview: We are looking for experienced Validation & Verification (V&V) experts to support protocol development and execution for the Elita system. The role requires independent ownership of end-to-end V&V activities with minimal onboarding or training. The candidate will contribute toward executing approximately 150–170 validation protocols within a defined timeline Key Responsibilities: · Independently author, review, and execute V&V protocols (IQ/OQ/PQ, system validation, software validation, etc.) · Ensure all validation activities comply with regulatory standards (FDA, ISO 13485, 21 CFR Part 820) · Drive end-to-end protocol lifecycle, including: o Protocol authoring o Test execution o Documentation and reporting o Defect tracking and resolution · Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory) · Provide SME-level inputs for validation strategy and risk-based validation approaches · Support audit readiness and documentation for regulatory inspections · Work in a high-paced environment with immediate delivery expectations Generic Managerial Skills, If any 1. Leadership 2. Communication Skills 3. Stakeholder Management 4. Decision Making 5. Problem Solving 6. Mentoring & Coaching 7. Conflict Resolution 8. Strategic Thinking 9. Time & Priority Management 10. Adaptability & Flexibility Desirable Skills: Keyword: Skills: ISO 13485~EIS : Medical Device & Regulations Experience Required: 10 & Above