Job Description

• 5 to 6 years of Process Validation (IQ, OQ & PQ) & test method validation experience
• Experience in process characterization, Gage R&R studies
• Knowledge in Statistical data analysis & Minitab
• Experience in working with Medical devices (especially implantable class III products like Pacemekers, ICD, CRTD etc) manufacturing – ISO 13485, 21 CFR 820 & Med dev
• Knowledge in Risk Management per ISO 14971 – PFMEA
• Knowledge in change control process
• Knowledge in fixture design