Quality IT Validation Specialist – On-Site in Juncos

Medial Group; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Medial Group in Juncos, Puerto Rico, seeks a qualified professional to lead validation of quality information technology systems in a regulated environment. The role requires formal documentation, SOPs, and coordination with clients, developers, and site personnel.

Desirable candidates have 5+ years in the regulated industry, experience with Process Validation and Computer System Validation, and a background in Medical Devices regulatory affairs. On-site work in Juncos, PR is required.

Qualifications

• Minimum 5 years of experience in the regulated industry.
• Experience in Process Validation and Computer System Validation.
• Experience in Medical Devices Regulatory and Technical background.
• Bachelor Degree in Science or Engineering completed.
• Bilingual.

Responsibilities

• Conducts a compliant validation process for quality information technology systems with formal validation documentation.
• Coordinates activities with clients, programmers/developers and operating personnel, domestically and globally as appropriate.
• Identifies requirements for compliant computerized operations and suggests methods for implementation and maintenance of procedures and documentation.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements and audit policies.
• Performs system administration and configuration of quality information technology systems.
• Performs other duties as assigned.

Skills

Process Validation

Computer System Validation

Regulatory Knowledge

Bilingual

Education

Bachelor Degree in Science or Engineering

Job description

Medial Group in Juncos, Puerto Rico, seeks a qualified professional to lead validation of quality information technology systems in a regulated environment. The role requires formal documentation, SOPs, and coordination with clients, developers, and site personnel.

Desirable candidates have 5+ years in the regulated industry, experience with Process Validation and Computer System Validation, and a background in Medical Devices regulatory affairs. On-site work in Juncos, PR is required.