Staffing - Quality Engineer IV

Job Description

• 100% remote, some travel to other Corning Life Sciences plants/locations may be required.
• Candidate must be willing to work EST hours.
• Focus of position is validating software systems (not developing or installing)
• Non-exempt

• Bachelors is a hard requirement. Minimum of 5 years experience pharmaceutical, medical device, and/or biotechnology industry manufacturing and product software quality engineering and/or assurance experience.
• Background in 21 CFR Part 11-compliant software validations, including systems such as inspection systems, vision systems, manufacturing execution systems, and material handling systems
• SAP software validation experience (the worker will be validating in SAP)
• Knowledge of applicable industry standards, regulations, and requirements (e.g. GAMP, medical device and pharmaceutical GMPs, ISO 9001, ISO 13485, Quality Systems Regulations 21 CFR part 820, EU IVDR and MDR)

• BS degree in a field relevant to the position

• Minimum of 5 years of pharmaceutical, medical device, and/or biotechnology industry manufacturing and product software quality engineering and/or assurance experience.