Sr Quality Engineer

Pay 50-60/h depending on experience Top 3 technical skills that are required for the role: 1. Technical Procedure Review and Writing 2. Understanding of NCMR requirements by FDA and ISO 3. The ability to accomplish both daily tasks and longer term tasks at the same time. Education Required: B.S. in Engineering Years’ Experience Required: 7-10 years of Medical Device experience In the role of Sr. Quality Engineer, the person will be asked to perform daily activities that include review and approval of Non Conformances, Document Changes and Validations. Along with daily activities, the person will perform reviews of local QMS Documents, compare them with Enterprise Level Documents, and make the required changes to the Local QMS documents to ensure adherence to the Enterprise Documents. Essential perform QMS Harmonization tasks between local document and Medtronic Enterprise level documents. Engineer may assume responsibility for leading Gemba Walks, documenting risks found during the walks and ensuring the risk get addressed. Must Have 3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry. Strong project management skills, with the ability to manage multiple priorities and deadlines. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions. Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders. Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability. Experience in Process Validation. Nice To Have SAP, Microsoft, Nonconformance, CAPA, Change Order #J-18808-Ljbffr