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 https://www.jnj.com/. Diversity, Equity & 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. We are searching for the best talent for Senior Source Quality Engineer to be in Sao Jose dos Campos, Brazil. Purpose: T he Senior Source Quality Engineer (Sr. SQE) provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products. The Sr. SQE will be responsible for external suppliers of direct and indirect materials, finished goods and services for the Ethicon franchise. He/she leads the deployment of the Source Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the Ethicon supply chain. This individual will l e v erage ta l ents and coordinate tea m s ( S Q E s and oth e r s), collaborate with Strategic Sourcing/Procurement, R&D, Engineering/Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve suppliers' quality and overall service and performance. In this role, the individual supports the execution of plans/strategies, and implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regards to the determination, selection, qualification, monitoring, and disengagement of suppliers. You will be responsible for : * P r ovide timely business support for the assigned Ethicon Source Quality Management (SQM) function globally. * Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management. * Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Source Quality Management. May lead this process under the guidance of Source Quality Manager and/or management representative. * Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems. * Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions * Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes. * Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects. * Own and lead the Source Quality Relationship Management (SQRM) process for the assigned suppliers (e.g. Lead periodic SQRM meetings including supplier quality performance reviews, supplier investigation follow-ups, investigation * Responsiveness/cycle time, targeted improvement plans (TIP), closed loop corrective actions, NC reductions, supplier quality metrics, etc.). * Lead component qualification change projects in collaboration with key business partners and the supplier's applicable functional groups * A minimum of a Bachelor's degree in Engineering, an Applied Science or a related technical and quality field is required. * A minimum of 4 years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required. * Prior manufacturing, plant or technical background is required. * Working experience in good manufacturing practice regulated environment is preferred ( med ic al de v ic e , ph a r m a c eut ic a l , et c.) . * Demonstrated knowledge of manufacturing principles and practices, and procedures. * Direct experience in plant and/or supplier GMP auditing is preferred. * Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required. * Experience with documentation and technical writing skills, in a regulated compliance environment, is required. * Demonstrated ability to identify compliance risks and assess business impact, is required. * Ability to manage complexity and work in a diverse team environment is essential. * Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards) required. * Working knowledge of Quality issue investigation, Non-Conformance Reports (NCRs), Corrective and Preventative Actions (CAPAs) preferred. * ASQ Certifications for Certified Quality Engineer (CQE), Quality Manager (CQM), and/or Supplier Quality Professional (CSQP) preferred. * Quality Auditor qualifications or Lead Auditor certifications such as ASQ Certified Quality Auditor (CQA) or Biomedical Auditor (CBA) preferred. * Ability to communicate effectively in English is required. * Bilingual in English and other language (Spanish, German, Portuguese, or Mandarin) is preferred.
