Hands-On Validation Engineer – Medical Devices

CIQA Computer Integration of Quality Assurance - Official; Añasco (PR); On-site; USD 48,000 - 55,000; Full time

Job summary

CIQA Computer Integration of Quality Assurance - Official in Puerto Rico seeks a hands-on Validation Engineer to support a site readiness project at a regulated manufacturing facility in Añasco. You will execute validation activities, author protocols and maintain QMS documentation.

Ideal candidates have experience in medical device validation, EO/EtO sterilization exposure is a plus, and can work independently while coordinating with suppliers and cross-functional teams.

Qualifications

• Bachelors degree in Engineering.
• Experience validating in a regulated industry.
• Hands-on authoring/executing validation protocols.
• Experience with QMS documentation & change controls.
• Minitab or similar statistical software experience.
• Experience with supplier qualification.
• Strong organizational and problem-solving skills.
• Excellent bilingual communication (English/Spanish).
• Ability to work independently with cross-functional teams.

Responsibilities

• Develop, author, and execute validation protocols and reports.
• Support site readiness and equipment qualification.
• Ensure validation activities meet regulatory standards.
• Prepare change controls and related technical docs.
• Collaborate with external suppliers to ensure compliance.
• Communicate progress and findings to stakeholders.
• Maintain accurate documentation per procedures.
• Independently perform hands-on validation tasks.

Skills

Validation execution

Documentation writing

Cross-functional collaboration

Communication skills

Bilingual English/Spanish

Education

Bachelors degree in Engineering

Tools

Minitab

Job description

CIQA Computer Integration of Quality Assurance - Official in Puerto Rico seeks a hands-on Validation Engineer to support a site readiness project at a regulated manufacturing facility in Añasco. You will execute validation activities, author protocols and maintain QMS documentation.

Ideal candidates have experience in medical device validation, EO/EtO sterilization exposure is a plus, and can work independently while coordinating with suppliers and cross-functional teams.