Quality Engineer II

Medial Group; Villalba (PR); On-site; USD 55,000 - 85,000; Full time

Job summary

Medial Group is seeking a Quality Validation Specialist to ensure compliant validation of quality IT systems in a regulated environment. The role involves documenting procedures, coordinating with clients and developers, and ensuring regulatory alignment across domestic and global operations.

You will validate computerized systems, report on validation progress, manage non-conformances, and drive CAPA activities to closure.

Qualifications

• Minimum 2 years of relevant experience in the regulated industry.
• Knowledge of Good Manufacturing Practices (GMP).
• Good problem-solving skills and attention to detail.

Responsibilities

• Conducts a compliant validation process for quality IT systems with required documentation.
• Coordinates activities with clients, developers, and operating personnel, domestically and globally.
• Identifies requirements for compliant computerized operations and maintains procedures and records.
• Reports on validation status to meet regulatory requirements.
• Performs system administration and configuration of quality IT systems.
• Investigates non-conformances and initiates CAPA actions.
• Leads complaint activities with Operating Units and ensures corrective actions are completed.

Skills

Quality Assurance

GMP Knowledge

Problem Solving

Documentation

Overtime Availability

Job description

Villlalba, Puerto Rico | Posted on 07/22/2025

• Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
  
• Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
  
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
  
• Reports on the status of validation activities to fulfill regulatory requirements.
  
• Performs system administration and configuration of quality information technology systems.
  
• Performs investigation non-conformance events
  
• Initiates, recommends, and provides solutions to the Non-Conforming Product as per procedures
  
• Verifies the implementation and effectiveness of non-conforming CAPA
  
• Executes job responsibilities as established in the procedures
  
• Follows the documentation procedures Non- Conformance Resolution
  
• Evaluating, Investigating & Completion of Non- Conformance
  
• Investigation ( Data gathering of Quality issue)
  
• Identify Corrective/Preventive Actions
  
• Implementing Corrective/Preventive Actions
  
• Lead complaint activities with the Operating Units members
  

Other duties may be assigned.

Requirements

• Minimum 2 years of relevant experience in the regulated industry.
  
• Knowledge of Good Manufacturing Practices.
  
• Good problem-solving skills
  
• Availability to work overtime and weekends when necessary.
  
• Willing to work 100% On-site in Villalba.