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
• 812+ 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
Salary Range: $100,000 - $120,000
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
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