QUALITY SYSTEMS MANAGER

Overview Join to apply for the QUALITY SYSTEMS MANAGER role at Johnson & Johnson MedTech . 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 Job summary Job Function: Quality | Job Sub Function: Quality Systems | Job Category: People Leader | Location: Sao Jose, Brazil (São José dos Campos, São Paulo, Brazil) Responsibilities Responsible for ensuring individual and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures, including ISO and any other regulations of the sites we supply. Disseminate and ensure adherence to policies, standards, and procedures in force within the company, as well as their alteration and updating when necessary. Maintain procedures related to NC, CAPA, Record Management, and Document Change, and provide support to users of these systems with proper understanding of the internal flows. Provide support on Failure Investigation (NC and CAPA), techniques, and statistical and managerial tools; lead all CAPA/NC related topics (CAPA/NC site lead). Maintain key metrics that support local/global Dashboards. Conduct local Management Review and provide data to other involved sites’/franchises Management reviews. Ensure compliance with internal and legal standards related to company records and information by defining procedures, filing methods, document storage, and retention/validity periods; ensure compliance with internal and global standards related to document control. Lead and/or participate in improvement projects, preparing and drafting management reports for monitoring and decision-making. Ensure the quality information system contains consistent and reliable data and indicators through proper monitoring and systematic control of regulatory standards and related documentation, critical analysis of impacts, and timely correction of deviations. Provide technical support to the production process regarding product characteristics and performance when requested. Evaluate quality processes by conducting and/or approving trend analysis, identifying gaps and improvement opportunities, and monitoring corrective and preventive actions. Communicate problems or opportunities related to the business to the next management level. Promote adoption of a quality culture at all levels of J&J Medical Brazil to meet company objectives and comply with applicable regulations and policies; ensure subordinates follow Environmental, Health, and Safety practices and that resources are available and in good condition. Develop the area’s budget planning and appropriately utilize the financial resources provided. Promote continuous improvement and achievement of quality objectives in company processes. Manage staff performance and take disciplinary action when necessary; empower the team to act with speed, agility, and accountability. Position reports to the Quality Director; responsible for a team of 5-7 people; manage the Quality System processes to ensure compliance with company requirements and site goals; interact with Manufacturing, Planning, Quality Operations, and Supply Chain locally and with global functions. Qualifications Bachelor's degree in Engineering, Administration, Pharmacy, Biology, or related fields, or proven experience in performing the activity. Master degree in Quality Engineering, People Management, Quality Management or related areas is desirable. Minimum of 6 years of Quality experience in a GMP and/or ISO regulated industry, with at least some leadership experience. Experience with Health Authorities and Audits. Experience in project management is desirable. Fluent in English is required. Knowledge, Skills, Abilities, Certifications Lean or Six Sigma (Green or Black Belt) certification desired. Verbal and written communication skills; training/education methodologies. Kowledge of Regulatory Standards; problem-solving and quality tools. Location and Travel Position based in São José dos Campos, on-site. Occasional travel for domestic and/or international territories. #J-18808-Ljbffr