Summary:

The Quality Engineer will support the development, review, and maintenance of quality systems and documentation in a regulated manufacturing environment. This role focuses on validation oversight, document evaluation, and continuous improvement of inspection and assembly processes.

Responsabilities:

• Review and assess OQ/PQ documentation for refrigeration systems.
• Lead and support Test Method Validation and Cleaning Validation activities.
• Collaborate with cross-functional teams to ensure compliance with internal and external quality standards.
• Work closely with automated machinery to monitor and improve quality performance.
• Develop and update incoming inspection documentation and procedures.
• Apply quality techniques to assembly and inspection lines to ensure product integrity.
• Support CAPA investigations, root cause analysis, and corrective actions.
• Participate in audits and regulatory inspections as needed.
• Other functions that may be assigned.

Qualifications:

• Bachelor’s degree in Engineering or related field.
• Minimum of 5 years of experience in Quality Assurance within a regulated industry (medical device preferred).
• Knowledge of validation protocols (TMV, Cleaning, OQ/PQ).
• Experience with automated manufacturing systems.
• Strong analytical, documentation, and communication skills.
• Fluent in English and Spanish preferred.

Work Methodology:

• 100% On-site 
• 13 months (1st Contract)
• Administrative Shift (if a special validation is required, a second shift may need to be scheduled based on the need).
• Professional Service Contract