Key Requirements:

• Bachelor's degree in Engineering or Science.
• Knowledge and experience with IT systems and integrations with manufacturing equipment.
• Minimum of 4 years of experience in Quality Systems, Computer System Validation (CSV), or regulated IT environments.
• Strong expertise in CSV lifecycle management.
• Experience authoring and reviewing validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, reports, and SOPs.
• Knowledge of FDA, GxP, ISO, and data integrity requirements.
• Experience managing documentation changes and change control processes.
• Strong quality and compliance leadership skills.
• Excellent cross-functional communication and stakeholder management abilities.

Preferred Qualifications:

• Experience 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:

• 100% on site job
• Full time job
• Location: Juncos, PR
• Administrative shift
• Type of industry: Medical devices
• Expected hiring month: July 2026
• Timeframe: November 2026