QCG3248 Quality Engineer

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:

• Reviewing and approving validations, procedures, measurement systems, inspections, computer software validation, calibration/pm docs.
• Performed and/or reviewed process validation (including cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV and knowledge in Med Devices regulations.
• Responsible for working and executing Design transfer activities
• Responsible for implementation of new products: design requirements validation, manufacturing controls
• Responsible for Risk management documentation: pFMEAs

Qualifications:

• Bachelor Degree in Engineering
• Performed and/or reviewed process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory)
• Knowledge in Med Devices regulations
• Experience working and executing Design transfer activities
• Experience with implementation of new products: design requirements validation, manufacturing controls Experience with Risk management documentation: pFMEAs
• Basic knowledge in statistics and designing validation strategies

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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