Summary from listing
The Quality Systems Engineer II supports the Corrective and Preventative Action (CAPA) process at Maple Grove, including CAPA investigations, product and material nonconformances, root cause analysis, corrective action plans, regulatory compliance, documentation, and effectiveness verification. The role mentors cross-functional teams, partners with quality and site leadership, tracks CAPA metrics, and supports continuous improvement. It requires a bachelor's degree, at least two years of medical device or pharmaceutical experience, knowledge of 21 CFR 820 and ISO 13485, and strong problem-solving and stakeholder-management skills. The position follows a hybrid model requiring at least three days per week in the local office, with no visa sponsorship or relocation assistance.
