Quality Engineer

Eqval•Juncos, PR

50d•Onsite

About The Position

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 projects and day-to-day manufacturing operations within a regulated environment. The ideal candidate will have 2–4 years of experience, with knowledge in nonconforming product handling, SPC, process validation, and quality documentation.

Requirements

Education: Bachelor’s Degree in Engineering.
Experience: 2–4 years of relevant experience in the Medical Device or regulated manufacturing industry.
Basic knowledge of quality operations in manufacturing, including nonconforming product handling, yield improvement, Pareto analysis, and defect bounding.
Familiarity with Statistical Process Control (SPC).
Fundamental understanding of Process Validation principles.
Requires skills in statistical analysis (Minitab).

Responsibilities

Support Engineering and Quality teams in projects and day-to-day manufacturing operations.
Work with Quality Systems, including the development, implementation, and/or evaluation of process nonconformities, CAPAs, and deviations.
Review and assess Failure Modes and Effects Analysis (FMEA) for both suppliers and manufacturing processes.
Develop, review, and manage quality and validation documentation, including change control processes and execution of validation protocols (IQ, OQ, PQ, etc.).