Quality Engineer

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.

We are seeking a Quality Engineer to support new product introductions (NPI) and product transfers into manufacturing operations. The ideal candidate will ensure products meet quality, regulatory, and operational requirements, while enabling successful launches and continuous improvement initiatives.

Key Responsibilities:

• Lead quality readiness for NPIs and product transfers.
• Review and approve quality deliverables, risk documentation, and process controls.
• Drive root cause investigations, CAPA implementation, and defect reduction.
• Develop and maintain product quality plans, risk analyses, and FMEAs.
• Collect and analyze manufacturing and quality data to support process improvements.
• Support audits and evaluate compliance against internal and regulatory requirements.

Qualifications:

• 5+ years in Quality or Process Engineering within FDA-regulated manufacturing (medical devices, pharma, biotech).
• Experience with NPIs or product transfers.
• Strong knowledge of 21 CFR Part 820, GMP, and ISO 13485.
• Hands-on experience with FMEA, CAPA, and root cause analysis.
• Strong analytical, documentation, and communication skills.

• Paid time off
• Health insurance
• Dental insurance
• Vision insurance
• Life insurance
• Employee assistance program
• Employee discount
• Professional development (certifications, courses & assistance)
• Referral program
• Holidays
• EQVAL Academy

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