Quality Engineer

Title: 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗘𝗻𝗴𝗶𝗻𝗲𝗲𝗿𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻: Ohio (OH)We are looking for a Quality Engineer to support Manufacturing Quality Operations within a medical device environment. The ideal candidate will have strong experience reviewing technical and validation documentation, evaluating statistical data and process capability, identifying gaps, and ensuring manufacturing and quality documentation is technically sound and inspection-ready.𝗞𝗲𝘆 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀:• Review validation, characterization, and manufacturing documentation for accuracy and compliance• Evaluate statistical analyses, process capability data, and technical reports• Identify data abnormalities, documentation gaps, and unsupported conclusions• Review equipment and process characterization reports• Evaluate acceptance criteria and technical conclusions• Support manufacturing quality and process improvement activities• Partner with cross-functional teams to resolve documentation and quality gaps• Support equipment qualification and validation activities as needed𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀:• Experience in Quality Engineering in the medical device industry• Strong knowledge of Design Controls and manufacturing processes• Experience reviewing technical and quality documentation• Strong technical writing and document review skills• Experience with statistical analysis, process capability, and data trends• Knowledge of IQ/OQ/PQ, PPQ, equipment qualification, and validation documentation• Experience with PFMEA, Control Plans, CTQ, CPP, URS, FAT/SAT, and technical reports• Strong critical thinking, problem-solving, and communication skills• Ability to challenge technical conclusions and identify quality/compliance gaps• Managerial references required