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 Responsible for directing, planning, organizing and controlling the processes, procedures, policies and activities for the assurance of the quality of the products according to the guidelines established by the clients and in compliance with the ISO 13485, reporting to Director Quality and Regulatory Affairs. ESSENTIAL DUTIES AND RESPONSIBILITIES: Plan and implement programs that ensure quality according to the requirements and guidelines of customers and in compliance with quality standards. Implements and drives the culture of continuous improvement. Manage the preparation, updating in the system of quality documentation, basing the processes on the standard of ISO 9001: 2015 and ISO 13485:2016 and FDA. Maintain daily communication with the Departments to follow the established processes and together take actions for the improvement or problems solution detected in the product or in the processes. Responsible to follow up and ensure that the personnel of the Department under her responsibility have the proper training to performance the job duties. Ensures adequate operational quality controls are developed to incorporate customer and regulatory requirements. Implements the risk based approach to the site QMS and operations. Regulatory ensure manufactured products are appropriately licensed, produced and marketed. Qualifications Bachelor\'s degree, with a minimum of 5 years in relatable work experience required. Minimum 2 years of supervisory experience. Excellent oral and written communication Strong knowledge in ISO 13485 and 21 CFR82 Strong management and communication skills Skills to make presentations to top management The incumbent is required to demonstrate a positive attitude on a consistent basis when working with others. Ability to work in matrix management and able to work... 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/17D9062A53DF4CEC