• Responsible for defining the validation strategy (MVP, IQ, OQ, PQ, GR&R) for new and/or improved processes or equipment.• Responsible for compliance assessments in regards to contact manufacturing materials per regulations Reach by RoHS, Prop 65, EU MDR.• Create and evaluate engineering documents for second and third level medical devices. Engineering documents composed for Control Plan, Process Failure Mode and Effect Analysis, Process Flow Chart diagram.• Responsible for initiating, implementing, and completing change control, quality deviations, investigations, impact/risk assessments, root cause analysis, and NCRs/SCARs/CAPAs.• Supervise and manage tasks of the Quality-Engineering technicians.• Assist with the strategy and technical tasks for relocation of a facility project.