CQV EnginnerMedical Device Validation Engineer

Title: Medical Device Validation Engineer

Location: San Diego CA

Duration: 6 months

Experience Required: 10 & Above

Skills: ISO 13485EIS : Medical Device & Regulations

Roles & Responsibilities

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

Must-Have Skills:

• Strong expertise in V&V for medical devices
• Hands-on experience in: Protocol writing (IQ OQ PQ CSV system validation) and Validation execution and reporting
• Deep understanding of: FDA regulations (21 CFR Part 820)
• ISO 13485 standards
• 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

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 ISOCFR Part 820)
• Drive end-to-end protocol lifecycle including:
• Protocol authoring
• Test execution
• Documentation and reporting
• 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

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