EQVAL Group, Inc. is a company that provides technical and engineering services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies) and other service companies. We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, to perform and provide a highly effective service.

The Quality Engineer will support product transfer activities from development through commercial release, with a primary focus on process validation, sterilization, final packaging, and first-time quality. This role ensures manufacturing processes and quality systems are compliant, capable, and ready to support commercial production in a regulated medical device environment.

Work Details:

• Environment: Medical Device / Regulated Manufacturing
• Location: Villalba, Puerto Rico
• Work Arrangement: Full-time, 100% on-site

Requirements:

• Education Required: Bachelor’s Degree in Engineering
• 3–6 years of experience in a regulated manufacturing environment (medical device preferred)
• Sterilization Knowledge – Experience supporting sterilization processes and validations in a regulated manufacturing environment.
• Final Packaging (Final Pack) – Knowledge of final pack operations, packaging validation, labeling, and product release.
• Process Validation & Quality Tools – Hands-on experience with process validation, statistical analysis, PFMEA, and First Time Quality initiatives.

Key Responsibilities:

• Support product transfer activities from development or pilot manufacturing into commercial production.
• Lead and support process validation activities to ensure manufacturing processes are compliant, capable, and ready for commercial release.
• Provide quality support for sterilization processes, including validation and release activities.
• Support and oversee final packaging (Final Pack) operations, including packaging validation, labeling, and product release.
• Ensure products are released to commercial manufacturing in compliance with Quality System and regulatory requirements.
• Perform and support Process Failure Mode and Effects Analysis (PFMEA) to identify, assess, and mitigate process risks.
• Drive First Time Quality initiatives to minimize deviations, rework, and scrap during product transfer and production ramp-up.
• Partner with cross-functional teams including Manufacturing, Engineering, R&D, Regulatory, and Operations to ensure smooth product transitions.
• Support risk management, change control, and documentation activities associated with product transfer and process validation.
• Provide quality oversight during process qualification, validation, and commercialization phases.

*Please note that this is a long-term position and requires 100% on-site presence in Villalba, Puerto Rico.*