About

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 Job Function: Supply Chain Engineering Job Sub Function: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: Cornelia, Georgia, United States of America, Guaynabo, Puerto Rico, United States of America Job Description: Johnson & Johnson is recruiting for a Staff Source Quality Engineer to be located in Cornelia, Georgia, or Guaynabo, Puerto Rico. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Staff Source Quality Engineer (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 Staff 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 leverage talents and coordinate teams (SQEs and others), 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. Key Responsibilities Provide 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. Experience and Education A minimum of a Bachelor's degree is required. A degree in Engineering, an Applied Science or a related technical and quality field is preferred. A minimum of 6+ 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 (medical device, pharmaceutical, etc.). 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. Component Qualification/Process Validation experience is preferred. New product introduction experience is desired. Prior experience with FDA inspections is desirable. Broad knowledge of Quality System Regulations and Source Quality Management principles is desired. Ability to manage complexity and lead a diverse team is essential. Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches. Required Knowledge and Skills 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) preferred. Knowledge of Non-Conformance Reports (NCRs) and Corrective/Preventative Actions (CAPAs) is a plus. Process Validation experience is preferred. Professional Certifications: ASQ CQE, CSQP, CMQ/OE, CSSGB, CSSBB, CQA, and/or Project Management are preferred. Strong analytical skills, metrics development and ability to identify trends are desirable. Knowledge of specific business practices and software applications skills (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project®) is preferred. Ability to collaborate with all levels of management in cross-functional team environment is required. Ability to communicate effectively in English. Bilingual in English and German is preferred. Travel Requirements This position may require up to 25% domestic and international travel Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. 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/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information