Quality Assurance Manager - **

Medix is seeking a proven, quality-minded individual who possesses strong design controls and risk management experience to support a regulated production team that we work with in Hartland, WI. If you're a Quality professional seeking their next challenge, consider applying today and let's connect!<br><br><strong>Job Summary</strong><br><br>Responsible for managing the quality and compliance for applicable products and processes for assigned department(s). Adapt departmental plans and priorities to address resource and operational challenges.<br><br><strong>Major Responsibilities</strong><br><ul><li>Ensure quality and regulatory compliance with applicable regulations (e.g., QSR, GMP, ISO) pertaining to the applicable life cycle and regions of distribution for the product.</li><li>Act as a liaison with Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.</li><li>Manage complaints and develop new approaches to solve problems identified during the investigation process.</li><li>Identify and manage the execution of continuous improvement projects.</li><li>Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint. Assist in the planning of design, testing, inspection, and process validations to ensure quality products or components.</li><li>Ensure all quality issues are resolved to customer satisfaction in a timely manner.</li><li>Resolve issues relating to product or production quality by interfacing with internal and external customers.</li></ul><br><strong>Management Responsibilities</strong><br><ul><li>Typically oversees professional employees/teams OR manages non-professional employees through Supervisors in manufacturing, distribution, or office environments.</li><li>Recommend and implement new policies or modifications to existing policies.</li><li>Provide general guidelines and parameters for staff functioning.</li><li>Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, and ensuring consistent application of organizational policies.</li></ul><br><strong>Job Requirements</strong><br><ul><li>Bachelor's degree in Engineering, Science, or a Technical Field.</li><li>At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).</li><li>At least 2 years of supervisory/managerial experience preferred.</li><li>Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.).</li><li>Advanced level skill in Microsoft Excel (e.g., using AVERAGE function, merging and centering cells, printing centered page, and/or creating a pivot table).</li><li>Position requires travel up to 25% of the time for business purposes (within state, out of state, and/or internationally).</li></ul>