Quality Engineer

Role & responsibilities

Lead end-to-end quality assurance for bioprocessing equipment, systems, fabrication, assembly, testing, documentation, and customer acceptance activities.

Ensure compliance with GMP, GAMP, 21 CFR Part 11, customer quality requirements, and applicable international standards for biopharmaceutical applications.

Establish and monitor inspection and testing requirements including dimensional inspection, pressure/leak testing, surface roughness, PMI, passivation, NDT, functional testing, and equipment performance verification.

Ensure accuracy, completeness, and traceability of quality dossiers, inspection records, material certificates, welding documentation, test reports, calibration records, deviation records, and customer documentation.

Preferred candidate profile

B.E./B.Tech Mechanical / Production / Metallurgy or equivalent.

4-8 years of experience in Quality Management, preferably within biopharmaceutical, pharmaceutical process equipment, biotech equipment, hygienic process systems, or high-purity stainless-steel equipment manufacturing.