Quality Assurance Specialist

EKF Diagnostics is seeking a full-time Quality Assurance Specialist based in Boerne, Texas to ensure the quality of manufactured products and processes in accordance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs).

Key responsibilities include overseeing validation activities, supporting cross-functional teams with quality events such as CAPA, NCR, and deviations, managing supplier quality programs, conducting training in cGMP and ISO standards, and maintaining document control systems.

Candidates should have a Bachelor’s degree in a science-related field and at least three years of quality experience in medical or in vitro diagnostic devices. Strong knowledge of ISO 9001, ISO 13485, ISO 14971, and 21 CFR Part 820 is required. Preferred qualifications include five years of experience, knowledge of calibration and supplier programs, and prior manufacturing experience. The role offers a collaborative environment with opportunities for professional growth.

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