Quality Manager - NAMIC

Job Summary 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. Responsibilities Ensure quality and regulatory compliance with applicable regulations (QSR, GMP, ISO) pertaining to the applicable life cycle and regions of distribution for the product. Act as liaison with the divisions, suppliers, manufacturing, and/or operations to ensure quality products and customer satisfaction. Manage complaints and develop new approaches to solve problems identified during the investigation process. Identify and manage the execution of continuous improvement projects. 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 assure quality products or components. Ensure all quality issues are resolved to customer satisfaction in a timely manner. Resolve issues relating to product or production quality by interfacing with internal and external customers. Oversee professional employees/teams or manage non‑professional employees through supervisors in manufacturing, distribution, or office environments. Contribute to budgetary impact; interpret and execute policies for departments/projects and develop new or revised policies. Provide general guidelines and parameters for staff functioning, including hiring staff, recommending pay increases, performing performance reviews, training and development, estimating personnel needs, assigning work, meeting completion dates, and ensuring consistent application of organizational policies. Requirements Bachelor’s degree in Engineering, Science, or Technical Field, or relevant experience. At least 4 years of experience related to design/operation of medical device or drug combination product platforms, design controls, risk management, and compliance with QSR/GMP/ISO requirements. Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR, etc.). Proficiency in analyzing and reporting data to identify issues, trends, or exceptions and driving improvement. Demonstrated ability to control and coordinate concurrent projects, competing priorities, and critical deadlines. Advanced skill in Microsoft Excel (e.g., AVERAGE function, merging/centering cells, printing centered page, pivot tables). Position requires travel up to 25% of the time for business purposes (within state, out of state, and/or internationally). Preferred Requirements At least 2 years of supervisory/managerial experience. Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries. Salary & Benefits Anticipated salary range: $116,000.00 - $174,000.00 annual. Role is bonus and/or incentive eligible. The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. Benefits include health insurance, life and disability insurance, 401(k) contributions, paid time off; an Employee Assistance Program, Employee Resource Groups, and Employee Service Corp. Employees working 30 or more hours per week receive the full benefit package; employees working less than 30 hours receive 401(k) contributions, paid time off, and access to the aforementioned programs. EEO Statement Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. #J-18808-Ljbffr Medline Industries, LP