Sr. Quality Application Specialist (Science)/ Sr. Quality Engineer (Engineer)

CIS International • Juncos, PR

1d • Onsite

About The Position

We are seeking a Sr. Quality Application Specialist (Science) or Sr. Quality Engineer (Engineer) to join our team. This role requires a strong understanding of quality systems, computer system validation (CSV), and regulated IT environments within the medical device industry. The ideal candidate will have a Bachelor's degree in Engineering or Science, with a minimum of 4 years of experience in relevant fields. You will be responsible for managing the CSV lifecycle, authoring and reviewing validation documentation, and ensuring compliance with regulatory requirements.

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.

Nice To Haves

• 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.

Responsibilities

• Manage the Computer System Validation (CSV) lifecycle.
• Author and review validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, reports, and SOPs.
• Ensure compliance with FDA, GxP, ISO, and data integrity requirements.
• Manage documentation changes and change control processes.
• Provide quality and compliance leadership.
• Communicate effectively across functions and manage stakeholders.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior