About this role
Quality Engineer (MN) at Excel Engineering, Inc.. Location: Mounds View, Minnesota, United States. Role: ensuring compliance, supporting validation, leading audits Requirements: Bachelor's in engineering/life sciences, 6+ years quality engineering experience in pharma or medical device, strong knowledge of FDA/ISO/GMP, CAPA, change control, risk management, audits, validation, and data integrity; willingness to travel up to 10%. Category: Engineering Seniority: Senior Level Tools: FDA 21 CFR Parts 11, 210/211, 820 (QMSR), ISO 13485, ISO 9001, EU MDR/IVDR, EU GMP, ALCOA+, ISO 14971, ICH guidelines, IQ/OQ/PQ, Computer System Validation (CSV), Computer Software Assurance (CSA) Certifications: cqe, cqa, eit Commitment: Full Time Workplace: Onsite Languages: English