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.

Responsibilities:

• Execute and support Test Method Validation and Cleaning Validation activities.
• Update and create inspection methods for products / components.
• Review / update instructions for manufacturing control inspections and other related documentation.
• Review validation documents such as IQ, OQ, PQ.
• Review and manage investigations.
• Collaborate with cross-functional teams to ensure compliance with internal and external quality standards.
• 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 or Engineering within a regulated industry (medical device preferred).
• Knowledge of validation protocols.
• Strong analytical, documentation, and communication skills.
• Fluent in English and Spanish preferred.

Work Methodology:

• 100% On-site & full-time project
• 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 services contract