Must Have Experience in equipment IQ Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation Process Validation Lifecycle (from process characterization, operational qualification to performance qualification) Preferred experience in DOE (with Minitab) Other Skills Computer and software validation CSV SOP Development Change control of Medical Devices Conducted test method validation analysis Creating Control Plans Creating inspection sampling plans Developing packaging validation plans Develop the Risk Evaluation Nice to Have 1-3 years medical Device experience Role Summary The Quality Engineer (QE) supports MDR remediation activities and ongoing manufacturing quality assurance for designated product families at the Dexter site. The QE collaborates closely with manufacturing, planning, warehouse operations, and product engineering to assess risks, implement process controls, and support product and process changes required for MDR compliance.