Quality Engineer

EQVAL•Juncos, PR

1d•Onsite

About The Position

EQVAL Group, Inc. provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others) and works with professionals to meet customer requirements. The company is seeking a Quality Engineer to support validation activities in a regulated manufacturing environment, with a strong involvement in process validation, equipment qualification, and quality systems compliance. This role requires hands-on experience in validation processes (PV and CSV), risk management, and regulatory documentation, supporting projects from requirements definition through execution. The position is on-site, full-time, and requires collaboration with cross-functional engineering and manufacturing teams in Juncos, PR.

Requirements

Bachelor’s degree in Engineering
4+ years of experience in validation processes within Pharma, Biotech, or Medical Device industries
Experience performing and/or reviewing Process Validation (PV: characterization, OQ, PQ) and Equipment Qualification (CSV: URS, FAT, IQ, OQ, PQ, TMV)
Basic knowledge of validation strategy development, including requirements flow-down from design to manufacturing
Experience with risk management documentation, including pFMEA
Basic knowledge of statistics (preferably using Minitab)
Experience supporting projects related to design requirements validation and manufacturing controls

Nice To Haves

Investigating manufacturing events in support of product disposition
Identifying and analyzing manufacturing defect and reject trends
Knowledge of Medical Device regulations (FDA, ISO, GMP, GAMP 5)
Experience with Design Transfer activities and execution

Responsibilities

Conduct compliant validation processes for quality systems requiring formal documentation under regulatory requirements
Develop, execute, and review validation documentation (URS, FAT, IQ, OQ, PQ, TMV, validation reports)
Support full validation lifecycle, including risk assessments, traceability matrices, and deviation management
Perform statistical analysis and support sampling plans for validation activities
Investigate manufacturing issues and support product disposition decisions
Track and analyze manufacturing trends, defects, and non-conformances
Coordinate with cross-functional teams, vendors, and engineering groups to support validation execution
Ensure compliance with FDA, ISO, GMP, and other applicable regulatory standards
Support audits, regulatory inspections, and continuous improvement initiatives
Report validation status and progress to ensure timely project completion