Electronic quality management system (eqms) implementation
Computer system validation (csv) and iq/oq/pq testing
Regulatory compliance with fda qsr and iso 13485
This role leads the global strategy and continuous improvement of the electronic Quality Management System to ensure regulatory compliance and data integrity
Job Summary
This role leads the global strategy and continuous improvement of the electronic Quality Management System to ensure regulatory compliance and data integrity.
The position requires developing and executing validation plans, protocols, and reports in collaboration with IT and system owners to maintain a validated state.
Hollister Incorporated offers a competitive total rewards package including above-market pay, comprehensive health benefits, and generous retirement savings.
Matching Summary
This role leads the global strategy and continuous improvement of the electronic Quality Management System to ensure regulatory compliance and data integrity.
Salary
Base: $108,000 - $155,000 yearly; Bonus/Equity: Eligible for Corporate Bonus Plan; Benefits: Health, dental, vision, 401(k) match, paid time off
Skills & Requirements
Must-have
Electronic Quality Management System (eQMS) implementation
Computer System Validation (CSV) and IQ/OQ/PQ testing
Regulatory compliance with FDA QSR and ISO 13485
Integration of eQMS with ERP, PLM, and MES systems
Data integrity assurance and audit support
Nice-to-have
Experience with TrackWise, MasterControl, or Veeva platforms
Knowledge of AI and cloud solutions for efficiency
Process mapping and gap analysis skills
Strong collaboration across IT and cross-functional teams
Agile mindset for adapting to digital changes
Key Requirements
Bachelor's Degree required
8-12 years of related experience
Deep understanding of medical device regulations (ISO 14971, EU MDR)