Proficient in managing the validation lifecycle independently.
Hands-on experience with IQ/OQ/PQ and CSV.
Strong knowledge of FDA regulations and ISO standards.
Capable of coordinating with multifunctional teams.
Experience with QMS tools like TrackWise or Veeva.
Responsibilities
Author and execute validation protocols, including IQ, OQ, PQ, and System Validation.
Manage test execution, documentation, and defect tracking throughout the validation lifecycle.
Ensure compliance with FDA 21 CFR Part 820 and applicable ISO standards.
Collaborate with R&D, Quality, Manufacturing, and Regulatory teams on validation.
Provide guidance on validation strategies and risk-based approaches.
Support audit readiness and regulatory inspections.
Drive multiple validation protocols simultaneously in a fast-paced environment.
Benefits
Opportunity to work with complex medical systems.
Join a team at the forefront of medical device innovation.
Support and guidance from cross-functional collaboration with industry experts.
Contribute to mission-critical processes in a regulated environment.
Engagement in a dynamic work environment.
Full Job Description
Job Summary:
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:
uthor, 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.
Experience:
8-12+ years of Medical Device V&V experience.
Proven track record as a Validation Subject Matter Expert (SME).
bility to work independently, manage priorities, and deliver under tight timelines.
