Must Have Technical/Functional Skills
Must-Have Skills
- Strong expertise in V&V for medical devices
o Protocol writing (IQ, OQ, PQ, CSV, system validation)
o Validation execution and reporting
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
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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