Quality Engineer II

Job Description Quality Engineer supporting MDR remediation and manufacturing quality for medical device products, focusing on process validation, risk management, and change control. Responsibilities Execute process & test method validations (IQ/OQ/PQ). Perform First Article Inspections (FAI) and reporting. Develop PFMEA, Control Plans, risk assessments. Support MDR remediation activities. Conduct packaging/fit testing and validation. Review and approve change orders (Agile PLM). Perform label verification and production support. Collaborate with manufacturing, engineering, warehouse teams. Requirements 2+ years Quality/Validation experience. Medical device experience preferred (MDR a plus). Bachelor's in Engineering (Quality/Mechanical/Biomedical/Industrial). Top Skills (Must Have) Process Validation (IQ, OQ, PQ). Validation lifecycle (process characterization → PQ). Test method validation & documentation. PFMEA, Control Plans, risk documentation. FAI, dimensional inspection, manufacturing change evaluation. DOE experience (Minitab preferred). CSV (Computer System Validation). SOP development. Inspection sampling plans. Packaging validation. Change control (medical devices). #J-18808-Ljbffr