We are seeking a Quality Engineer to support manufacturing quality operations in a regulated medical device environment. This role is responsible for ensuring product quality, supporting production activities, and maintaining compliance with ISO 13485 and FDA requirements. The Quality Engineer will play a key role in driving product quality, supporting manufacturing and process transfers, and strengthening the Quality Management System (QMS) through hands-on floor support and structured problem solving. Key Responsibilities Production Quality Support Support in-process inspection, final release, and lot history record review Lead MRB activities and disposition of nonconforming material Support supplier and customer quality issue resolution Monitor supplier quality performance and corrective actions Review complaints and returned product investigations Quality Systems & Compliance Support ISO 13485 and

FDA 21 CFR

Part 820 compliance Participate in internal and external audits and audit readiness activities Lead or support CAPA investigations and root cause analysis Support risk management activities (PFMEA, control plans) Support change control and documentation updates Process & Facility Transfer Support Support quality oversight of process and facility transfers Partner with engineering and operations on validations and requalification activities (IQ/OQ/PQ) Update inspection methods, control plans, and quality documentation during transfers Ensure process controls, SPC, and quality metrics are implemented and maintained Continuous Improvement Analyze quality trends and support data-driven improvements Improve inspection methods, sampling plans, and process controls Support cross-functional problem solving and operational improvements Qualifications 5+ years of quality engineering experience in medical device or regulated manufacturing Strong knowledge of ISO 13485 and

FDA 21 CFR

Part 820 Experience with CAPA, root cause analysis, and audit support Experience supporting manufacturing operations and production floor quality issues Familiarity with SPC, MSA, and statistical tools (Minitab preferred) Experience supporting product or process transfers strongly preferred ASQ certification (CQE/CQA) preferred Must be eligible to work in the United States without restriction and without the need for current or future sponsorship. Resumes can be confidentially sent to eli.stader@gogpac.com or call direct at (319)774-8916.