CUSTOMER QUALITY DIRECTOR

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: People Leader All Job Posting Locations: Ciudad Juarez, Chihuahua, Mexico Job Description: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech About Electrophysiology Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. As Johnson & Johnson MedTech Electrophysiology, we have one goal – to ensure those with atrial fibrillation can live the lives they want. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrythmia treatment. Our suite of tools means electrophysiologists are empowered to personalize their approaches for patients with effective and reproducible workflows. Together, we’re changing what it means to be diagnosed with atrial fibrillation or other cardiac arrhythmias. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for COSTUMER QUALITY DIRECTOR for Salvarcar Site, Ciudad Juarez Purpose: The Director, Worldwide Customer Quality, will take a leadership role in the administration of all facets of the customer complaint handling process to assure that the Company is providing effective customer service and fulfilling regulatory requirements. You will be responsible for: Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations and Johnson & Johnson procedures and guidelines, this position: Serves as the single point of contact for complaint handling for either the EP/NV. Manages the daily process and teams responsible for: Opening domestic and international complaint files Assigning complaints Updating complaint databases Tracking investigation status Assisting failure investigations Quality release of serviced and repaired devices (Ethicon only) Customer responses and complaint filing Provides support to associates preparing and submitting MedWatch and other international reports. Oversees research and data analysis to respond to information requests related to reportable complaints and submits follow-up reports as required to regulatory agencies. Implements procedures, training, and systems to support complaint handling for new product launches and lifecycle management. Owns and leads worldwide complaint intake and investigation processes. Coordinates all Health Authority interactions related to complaint handling. Acts as the point of contact during audits and inspections involving complaint handling. Manages projects related to: New product introductions Business acquisitions Complaint handling integration and representation Provides analysis of complaint trends to Quality, Operations, and Technical Management. Provides complaint information to Marketing and R&D to support continuous improvement initiatives. Utilizes statistical tools to communicate field product quality information. Trains Sales, Marketing, and Operations personnel on complaint handling requirements. Executes departmental financial planning and budget tracking. Develops team members and promotes a Credo-based culture. Establishes strong partnerships with: Medical Affairs Customer Call Center Quality Operations R&D Professional Education Service Sales Marketing Participates in strategic planning to improve customer response quality and timeliness. Communicates business issues and opportunities to senior management. Ensures team compliance with Health, Safety, and Environmental requirements. Ensures compliance with all applicable federal, state, local, and company regulations, policies, and procedures. Performs additional duties as assigned. Qualifications / Requirements: Required BA/BS/BSN in a Scientific, Technical, Engineering, or Nursing field. Demonstrated leadership capabilities. Medical Device, Diagnostics, or other regulated healthcare industry experience. Experience working in multi-site and matrix organizations. Minimum 7 years of relevant experience. Prior people leadership/supervisory experience. PreferredKnowledge of statistical applications. Knowledge of auditing practices. General CompetenciesQSR / ISO knowledge Product and process knowledge Quality Systems knowledge Ability to manage multiple priorities Confidentiality and discretion Project management skills Customer service orientation Presentation skills Conflict management Analytical skills Specific CompetenciesBasic knowledge of liability law Basic product-use knowledge Process Excellence/statistical methodologies MDR and Vigilance regulations Regulatory submission practices Product complaint systems Auditing and compliance practices General QA technical knowledge Customer relations skills Required Skills: Preferred Skills: Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Succession Planning