Validation Lead: IQ/OQ/PQ & Cross‑Functional Quality

Medial Group; Ponce (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Medial Group in Puerto Rico is seeking a driven professional to lead or support cross-functional teams in equipment and process validation for medical devices. This role emphasizes collaboration across project management, planning, and line management to ensure quality and timely delivery.

The candidate will develop, generate, and execute IQ/OQ/PQ validation protocols, review budgets and schedules, and maintain thorough documentation to meet regulatory expectations.

Qualifications

• Minimum of 2 years of hands-on experience with equipment and process validation in a regulated industry.
• Experience developing and executing IQ/OQ/PQ validation protocols.
• Knowledge of process characterization and validation lifecycle.
• Familiarity with statistical tools for sampling and process evaluation.
• Proven skills in project management and cross-functional coordination.
• Excellent analytical, organizational, and communication abilities.

Responsibilities

• Lead or support cross-functional teams to evaluate, develop, and manage validation projects.
• Oversee operational aspects of ongoing projects and liaise between teams and management.
• Maintain documentation of validation activities, deviations, and reports.
• Ensure compliance with quality, safety, and regulatory standards.
• Monitor project performance and ensure on-time delivery of milestones.

Skills

Cross-functional coordination

Project management

Analytical skills

Strong communication

Statistical data analysis

Regulatory compliance understanding

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

IQ/OQ/PQ

Job description

Medial Group in Puerto Rico is seeking a driven professional to lead or support cross-functional teams in equipment and process validation for medical devices. This role emphasizes collaboration across project management, planning, and line management to ensure quality and timely delivery.

The candidate will develop, generate, and execute IQ/OQ/PQ validation protocols, review budgets and schedules, and maintain thorough documentation to meet regulatory expectations.