Director, Quality Operations - Medical Devices, Cleanroom and Consumer Goods
Owens & Minor, Inc.
At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers-and their patients-are at the heart of what we do. Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. Owens & Minor teammate benefits include: * Medical, dental, and vision insurance, available on first working day * 401(k), eligibility after 30 days of employment * Employee stock purchase plan * Tuition reimbursement * Development opportunities to grow your career with a global company Summary Provide leadership and direction in the implementation of end to end prevention-based quality systems to ensure the development, manufacture, and distribution of medical devices, cleanroom products and consumer goods are safe, effective and meet regulatory requirements. Responsible for the management of staff level design and sustaining quality engineering, contract manufacturing operations and multiple manufacturing plant QA organizations located globally. Drive compliance to internal and external regulatory requirements. Facilitates the closure of significant quality and product issues. Works closely with Product Supply/Manufacturing and R&D to support business objectives. The Director of Quality Operations reports to the Vice President of Global Quality Assurance, Global Products. This position has considerable global responsibility including direct reporting of manufacturing site QA operations, as well as staff quality engineering: 1) Executing and implementing enhancements to existing QA functional systems in a manner that effectively supports the growth of the business. To that end, a key responsibility of this position is to have an understanding the Divisions business needs and strategic plans. The incumbent acts as a liaison with Suppliers, Manufacturing, Research Development to ensure quality products, customer satisfaction and 2) The development and implementation of quality engineering practices and product evaluation methods across the organization to ensure product quality meets regulatory and customer expectations to include but not limited to: risk management, new product development quality assurance, process validation, quality control planning and statistical and process controls. 3) Managing the deployment and execution of root cause analysis tools to support nonconformance, complaint and CAPA investigations. The incumbent sits on the Quality Review Board and assists in determining the need for field action associated with significant quality issues. Core Responsibilities * Provide Quality functional leadership and expertise to global organization such that it contributes to the development, manufacture, and distribution of safe and effective products. * Ensures quality and regulatory compliance with applicable regulations (e.g. QSR, GMP, ISO, MDSAP, MDR) pertaining to the applicable life cycle and regions of distribution for the products. * Develop programs and procedures that will provide leadership and direction in assuring successful implementation of staff QA functional systems, and help enhance manufacturing plant prevention-based quality awareness. * Establish and implement quality engineering programs for all product, process, or material changes related to commercially marketed product, including product improvements and line extensions. * Manage the risk management and new product development quality assurance program. * Establish and maintain a strong failure investigation resolution system for all internal and external quality issues. Interact directly with product supply, marketing, R&E, and other departments, as required with respect to product failure reporting and investigation. * Manage all aspects of plant-based quality including cost reduction, process reliability, problem resolution, complaint investigation, document control, and CAPA. * Directs CAPA activities and maintains the CAPA system. Including initiation, support of the root cause investigation, closure, and verification of effectiveness. Ensures compliance to applicable regulatory and corporate standards/requirements (e.g. FDA Quality System Regulations, MDR, ISO, etc.). * Establish and maintain a strong complaint resolution system through the Product Surveillance process. Interact directly with product supply, marketing, R&E, and other departments, as required with respect to product failure reporting and investigation. * Provides functional direction on Supplier Quality activities; working with Product Supply, develops and uses appropriate supplier selection, qualification, and management strategies. * Provide for training in technical, managerial, and administrative skills in order to meet the development needs of team members. * Provide functional direction to the Quality teams by implementing and maintaining quality policies, instructions, and control procedures. * Provide leadership to ensure the organization attracts, develops and retains the best talent management. Qualifying Experience * A four year degree in the physical sciences or engineering * 12-15+ years broad Quality Operations background * Strong experience in a manufacturing environment * Experience should include in-depth knowledge of domestic (FDA) and International regulatory requirements for the medical device industry * A good working knowledge of Spanish would be desired. If you feel this opportunity could be the next step in your career, we encourage you to apply. Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.