"Alerted.org

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

+ Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning process) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory).

+ Experience in production line.

+ Basic knowledge in defining validation strategies (e.g. requirements flow down from design to manufacturing).

+ Experience with Risk Management documentation: pFMEAs.

+ Basic knowledge in statistics (preferably using Minitab).

+ Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence).

Qualifications:

+ Bachelor's degree in Engineering (Mechanical, Electrical or Chemical preferred)

+ Minimum of 2 years of Engineering experience.

+ Knowledge in Medical Devices regulations.

+ Experience in GMP documentation.

+ Experience working and executing Design transfer activities.

+ Must be available to work all shifts and overtime.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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