Responsibilities for developing & executing complex validation activities for medical device manufacturing processes & equipment, including Installation Qualification (IQ), Operational Qualification (OQ), & Performance Qualification (PQ).
Bachelor's or foreign equivalent degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a closely related engineering field of study with minimum 3 years of professional experience in: (i) working with Manufacturing Execution System (MES); (ii) risk management activities such as identifying, evaluating, & prioritizing risks by assessing their probability & severity in alignment with FDA, ISO 13485 & 14971; (iii) ensuring compliance with Good Manufacturing Practice (GMP) & Good Documentation Practices (GDP); (iv) overseeing test method validation activities, ensure that test methods produce repeatable & reproducible results, & lead deviation investigations, troubleshooting issues, & generating deviation reports; (v) performing Failure Mode Effects Analysis (FMEA) & Root Cause Analysis (RCA) for equipment & processes & ensuring the implementation of corrective & preventive actions through CAPA management; & (vi) validation activities for medical device manufacturing processes & equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
An EOE. 40 hrs/week. Send resumes to [email protected] or by mail to Abbott Laboratories, Attn: 26J14A, Willis Tower, 233 S. Wacker Dr., Floor 26, Dept. 32, Chicago, IL 60606. Refer to ad code: SJM-0067-ES.
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