The QE Sustaining will work to assess, analyze, and trend quality of incoming materials (lot to lot variation) in order to ensure reduction of variation in the product manufacturing process. Responsible for dispositioning non-conforming product and driving root cause during investigations, with appropriate CAPA to prevent reoccurrence.
- Create product and process workflows to ensure best engineering practices within the quality and engineering teams for DFA/DFM (DFMA) into sustainable engineering and commercial operations
- Develop sampling plans for OQ/PQ activities, Master Batch Records, work instructions and associated documentation
- Drive root cause analysis of deviations/complaints.
- Maintain project deliverables to support manufacturing strategy, capability analysis, FMEA, risk management, cost modelling, DFM, and process validation/qualification.
- Participate in External Audits of Suppliers/Contract Service Providers.
- Minimum of 3 years in an FDA regulated industry, preference for med device/combination products experience
- Proficiency with business and technical software (ERP and eQMS)
- Ability to drive root cause analysis and critical thinking for complex problem solving