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Validation & Verification SME

Karwell Technologies

San Diego, CA

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JOB DETAILS
SKILLS
Bug Tracking/Defect Management, Code of Federal Regulations, Communication Skills, Documentation, Documentation Review, FDA (Food and Drug Administration), FDA Requirements, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing Requirements, Medical Equipment, Process Validation, Regulations, Research & Development (R&D), Risk, Risk Management, System Validation, Systems Administration/Management, Validation Plan, Validation Testing, Writing Skills
LOCATION
San Diego, CA
POSTED
18 days ago
Job Description:
  • We are seeking an experienced Validation & Verification (V&V) SME with 8 12+ years of experience in the Medical Device industry.
  • The ideal candidate will independently lead end-to-end validation activities, including protocol authoring, execution, reporting, and compliance management for complex medical systems in a regulated environment.
Roles & Responsibilities:
  • Author, review, and execute validation protocols including IQ, OQ, PQ, System Validation, and CSV.
  • Manage the complete validation lifecycle, including test execution, documentation, defect tracking, and reporting.
  • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
  • Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to support validation activities.
  • Provide SME-level guidance on validation strategies and risk-based validation approaches.
  • Support audit readiness, regulatory inspections, and documentation reviews.
  • Drive multiple validation protocols simultaneously in a fast-paced environment.
  • Strong expertise in Medical Device Validation & Verification (V&V).
  • Hands-on experience with IQ/OQ/PQ, Computerized System Validation (CSV), and System Validation.
  • Deep understanding of FDA regulations, ISO 13485, and ISO 14971 Risk Management.
  • Experience working in highly regulated environments with minimal supervision.
  • Excellent documentation, communication, and stakeholder management skills.
  • Experience with complex medical systems such as imaging, surgical, or similar platforms.
  • Familiarity with QMS tools such as TrackWise, Veeva, ETQ, or equivalent.
  • Experience supporting large-scale validation programs with 100+ protocols.
  • Prior onsite client engagement experience in the United States.
Requirements:
  • 8 12+ years of Medical Device V&V experience.
  • Proven track record as a Validation Subject Matter Expert (SME).
  • Ability to work independently, manage priorities, and deliver under tight timelines.

About the Company

K

Karwell Technologies

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