Quality Engineer

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

The Quality Engineer will support manufacturing operations in a regulated medical device environment, with a primary focus on validations, investigations, and risk management activities. This role requires close collaboration with Engineering, Manufacturing, and Quality teams to ensure compliance, product quality, and the successful execution of projects aligned with regulatory standards.

Requirements & Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, or Chemical preferred)

• 3–5 years of experience in Quality or Engineering (excluding laboratory) within a regulated industry.

• Experience with risk management documentation (pFMEA)

• Basic knowledge of statistics (Minitab)

• Experience designing validation strategies (requirements flow-down from design to manufacturing)

• Hands-on experience investigating manufacturing operations events to support product disposition

• Experience assessing and tracing manufacturing defect/reject trends

• Experience performing and/or reviewing process and equipment validations (URS, FAT, IQ, OQ, PQ, TMV) – excluding laboratory and cleaning.

• Strong knowledge of medical device regulations (FDA, ISO 13485, EU MDR)

• Experience with projects involving design requirements validation and manufacturing controls (not Operational Excellence initiatives)

• Expertise in CAPA, investigations, root cause analyses, and technical writing

• Strong critical thinking and problem-solving skills with a focus on risk management (pFMEA)

• Experience in process and computer system validations

Responsibilities

• Lead and support nonconformance investigations, root cause analysis, and CAPA implementation

• Review and execute validation protocols for manufacturing processes and equipment (URS, FAT, IQ, OQ, PQ, TMV)

• Analyze yield, defect, and trend data to identify quality issues and drive improvements

• Develop, assess, and maintain pFMEAs for suppliers and manufacturing processes

• Collaborate with cross-functional teams to ensure validation and risk management compliance throughout the product lifecycle

• Review, develop, and maintain quality documentation in alignment with regulatory and internal requirements

• Support projects involving design requirements validation, manufacturing controls, and process improvements

• Apply statistical methods (SPC, Minitab) to monitor and enhance product and process performance

• Investigate customer complaints, determine root causes, and recommend corrective actions

Work Details

• Location: On-site, Juncos, PR (full-time)

• Schedule: 1st & 2nd shift, including weekends depending on production/project needs

• Hours: 40 hours per week

On-site role – Applicants must currently reside in Puerto Rico