JOB REQUIREMENTS: Company Description RRD is a leading global provider of marketing, packaging, print, and supply chain solutions that elevate engagement across the complete customer journey. The company offers the industry\'s most trusted portfolio of creative execution and world-wide business process consulting, with services designed to lower environmental impact. With 22,000 clients, including 93% of the Fortune 100, and 32,000 employees across 28 countries, RRD brings the expertise, execution, and scale designed to transform customer touchpoints into meaningful moments of impact. Job Description RRD - Plover, WI is a medical device contract manufacturing facility. The Quality/Regulatory Manager is responsible for directing, planning, organizing and controlling the processes, procedures, policies and activities for the assurance of the quality of the products according to specifications and in compliance with FDA 21CFR820 & ISO 13485, reporting to Director Quality and Regulatory Affairs. This role will ensure all processes, materials, and practices comply with quality system requirements. Reporting to the Quality Manager, will work closely with Operations, Customer Account team, Industrial Engineering, Supply Chain and other departments to resolve quality issues with processes, products, and materials. *RELOCATION ASSISTANCE AVAILABLE! Maintain and manage the Quality Management System to ensure compliance to ISO 13485-2016, FDA 820, and other international QMS standards as applicable. Drive continuous improvement within the Quality Management System. Develop work instructions, SOPs, and train all levels of staff to controlled documents. Promote Quality Culture throughout the organization. Train and mentor junior engineers, technicians, and inspectors. Perform analyses of programs and prepares responsive quality plans, procedures, schedules, and resource allocations for top-quality support. Communicate with internal and external customers and vendors to resolve quality issues with process, product and material inclusive of Root Cause Investigation, Corrective and Preventative action and monitoring for effectiveness. Provide support for Assembly/Test/Inspection personnel, including executing workmanship improvement plans, developing inspection methods and criteria, specifying appropriate sampling plans, interpreting and revising specifications, and processing non-conforming materials. Lead in resolving... For full info follow application link. RR Donnelley is an EEO/AA including Vets and Disabled Employer RR Donnelley is an Equal Opportunity/Affirmative Action employer. The company\'s policy is to select, place and deal with all its employees without discrimination based on race, religion, color, national origin, sex, gender identity or expression, age, disability, perceived disability, sexual orientation, protected Veteran status, genetic information or on the basis of any other status protected by applicable federal, state or local law. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/D5C7D71B86ED4A40