Main Responsibilities:

• Lead and execute Computer System Validation (CSV) activities for Quality Information Technology systems in compliance with FDA, GxP, ISO, and global regulatory requirements.
• Conduct and maintain formal validation documentation, including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols and reports, and supporting SOPs.
• Coordinate validation efforts with IT, system owners, developers, vendors, and operational users, including global stakeholders when applicable.
• Provide quality and compliance leadership to peers, serving as a subject matter expert on CSV best practices and regulatory expectations.
• Support and assess documentation and system changes through formal change control and impact assessments.
• Identify current and future regulatory requirements for computerized systems and recommend strategies to ensure ongoing compliance.
• Perform system administration and configuration for Quality IT systems (e.g., QMS, CAPA, Document Control, Training, Complaints).
• Monitor, track, and report validation status to ensure audit and inspection readiness.
• Stay current with evolving regulatory requirements, audit trends, and industry best practices related to computerized systems and data integrity.
• Support internal and external audits and regulatory inspections, including preparation and response to findings.

*Other duties may be assigned*

Requirements:

Education and Experience

• Bachelor’s degree in Engineering completed. 
• 4+ years of experience in Quality Systems, Computer System Validation (CSV), or regulated IT environments.
• Strong expertise in Computer System Validation (CSV) lifecycle management.
• Proven experience with quality documentation authoring and review, including validation and SOP documentation.
• Knowledge of FDA, GxP, ISO, and data integrity requirements.
• Experience managing documentation changes and change control processes.
• Demonstrated quality and compliance leadership and ability to influence peers.
• Strong cross-functional communication and stakeholder coordination skills.

Preferred / Nice to Have:

• Experience in medical device and/or pharmaceutical manufacturing environments.
• Experience supporting global or multi-site quality systems.
• Familiarity with electronic Quality Management Systems (QMS) such as Trackwise, ETQ, Master Control, or Veeva.
• Experience supporting regulatory audits and inspections related to computerized systems.

Work Methodology:

• Full time contract
• 100% on-site job in Medtronic- Juncos, PR
• Administrative Shift
• 2 years of first contract based on performance and budget availability.