Complaint Management Business Unit Manager

At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.We are in this for life.We are changing the trajectory of human health, YOU CAN TOO.**We are searching for the best talent for Complaint Management Business Unit Manager to be in Ciudad Juarez, Mex.****Purpose**:Under minimum supervision, the Complaints Management Business UnitManagerwill be responsible for supervising the Failure Analysis Lab and the Complaints Analysts in the Juarez Facility. This individual will also be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards.**You will be responsible for**:Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:- Responsible for WW Complaints entry, management, and closure.- Responsible forassuring compliance with BWI and J&J timeliness metrics.Develops, mentors, plans and coordinates workload for Complaints Quality Engineers and Complaints Analysts.- Responsible for conducting Performance Reviews and set Goals & Objectives for Complaints Quality Engineers and Complaints Analysts in the Juarez Facility.- Plans, develops, coordinates, and directs projects with varying levels of complexity.- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.- Responsible for ensuring the Complaints Handling Unit documents all required information for complaint files is obtained and properly documented to make sound regulatory reporting decisions.- Evaluates all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.- Guarantees all required regulatory reports are completed and reported according to regulatory requirements.- Establish reports for the prompt review ofnew complaints, regulatory reporting decisions, and follow-up.- Possess a thorough understanding of the complaint database.- Ensure the development, preparation, analysis, and presentation of trend reports for complaints.- Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service and Technical Services.- Understands principles, theories, concepts and techniques related to customer complaints.- Investigateand develop solutions to procedure and process related issues.- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.- Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate. Assist in complaint analysis. Assist Regulatory Affairs in developing submissions for new devices as necessary.- Work is expected to result in the development of new or improved techniques or procedures.- Develop and establish effective quality control and associated risk management plans as needed.- Responsible for reviewing regulatory reports and work with worldwide groups to assure regulatory compliance in countries outside UnitedStates.- Responsible for communicating business related issues or opportunities to next management level.- Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.- Responsible for ensuring personal and Company co