Manager Quality Process

Job Summary Responsible for managing a team of quality process specialists and leading the strategic implementation of items and events related to Quality Systems Management and CAPA. Manage the Quality data integrity for Medline products, including sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements. Responsibilities Lead personnel and activities to establish and maintain quality systems, including trending, analysis, and reporting of quality metrics. Collect, analyze, and report quality data to track performance and compliance. Develop and implement improvements to processes and procedures for the team and Medline. Identify, lead, and drive opportunities to improve quality systems independently and through the team, and develop long‑term strategies that support business success. Develop, assess, and define key quality metrics and indicators to track performance and compliance. Review and determine the application of various system compliance regulations. Ensure compliance with global regulatory requirements and internal procedures, and identify risk and compliance opportunities. Execute responsibilities as a CRB team member. Lead the CRB team in systems analysis and effectiveness measures. Train and coach personnel to deliver optimal results based on departmental goals. Manage professional employees, including day‑to‑day operations, workload, and other duties. Develop a strategy and manage the relationship with notified bodies for quality system evaluation. Manage and coordinate Notified Body/Registrar quality system registration strategy, host and coordinate audits, and support customer and regulatory audits. Manage day‑to‑day activities and outcomes of a group of employees as a working manager. Hire staff, recommend pay increases, perform performance reviews, train and develop staff, estimate personnel needs, assign work, meet completion dates, and ensure consistent application of organizational policies. Qualifications Education Bachelor’s degree in a technical or scientific discipline. Work Experience At least 7 years of experience with medical device or pharma Quality Management Systems, including at least 1 year of people‑management experience. Knowledge / Skills / Abilities Knowledge of FDA QSR and ISO standards. Proficiency in Microsoft Suite, MS Visio, MS Project, and Minitab. Travel up to 10% of the time for business purposes. Preferred Qualifications Experience with medical device and pharma across multiple product types and regulatory jurisdictions. Experience with quality system development and implementation. Experience with Device Design Controls, CE technical file requirements, and 510(k) submissions. Experience hosting FDA/ISO GMP inspections. Experience with SAP and ETQ Reliance. Anticipated Salary Range $110,240.00 – $165,360.00 Annual (varies by location, education, experience, and skills) Benefits Medline Industries, LP and its subsidiaries offer a competitive total rewards package, continuing education and training, and tremendous potential with a growing worldwide organization. Benefits include health insurance, life and disability coverage, 401(k) contributions, and paid time off for employees working 30 or more hours per week on average. For employees working less than 30 hours per week, benefits include 401(k) contributions and access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career and we strive to do this by seeking diversity in all forms, acting inclusively, and ensuring people have the tools and resources to perform at their best. 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