Staff Source Quality Engineer – Strategic Initiatives

Ethicon Endo Surgery Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Source Quality Engineer – Strategic Initiatives; position permitted to be based in Somerville, NJ; Guaynabo, Puerto Rico; West Chester, PA; Cincinnati, OH; Raynham, MA; Warsaw, IN. The Ethicon business offers a broad range of products, platforms, and technologies – including sutures, harmonic & electrosurgical instruments, surgical staplers, clip appliers, trocars, and synthetic mesh devices – that are used in a wide variety of surgical procedures. We combine products and services of two outstanding legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the landscape of open surgery. Ethicon Endo-Surgery was established 30 years ago in Cincinnati, Ohio, developing innovative devices that have driven the groundbreaking shift from open to minimally invasive surgery that continues to lead the industry today. As part of the Medical Devices sector, Ethicon brings people together from around the world to advance surgery and have life-changing impacts in healthcare. We offer healthcare professionals solutions that address the key challenges of today’s surgical procedures in order to optimize patient outcomes. Our devices offer the surgeon options for access, advanced energy, ligation, hernia repair and fixation, surgical stapling, uterine and pelvic surgery, wound closure, and biosurgery. We bring advanced devices to the world. The Staff Source Quality Engineer – Strategic Initiatives, will be responsible the deployment of the Source Quality strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the Medical Device sector of Johnson & Johnson. This position also may engage with the associated external suppliers of direct & indirect materials, finished goods and services. This individual will actively leverage talents and lead teams (SQEs and others), collaborate with Strategic Sourcing/Procurement, R&D, Engineering/Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement fit for purpose solutions and improve suppliers’ quality and overall service and performance. In this role, the individual supports the development and 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. She/he proactively identifies opportunities related to supplier performance and associated purchasing controls processes that leads to the improvement of suppliers. She/He implements appropriate Quality Engineering methodologies, process redesign, statistical techniques, process capability analyses/improvements, DOE/process optimization, and other technical or Process Excellence (PEx) tools in support of supplier-related changes, risk management, product/process transfers, innovations, and continuous process enhancements to improve supplier reliability, minimize risks, and ensure sustainable sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements. DUTIES & RESPONSIBILITIES Drive and manage Purchasing Controls related processes across the MD sector Source Quality function globally. Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management, SQ Agreements, etc. across all MD sector Business Unit/Franchise Quality Systems Develop and enable processes in support of the identification, selection, qualification, monitoring, and disengagement of suppliers. Implement supplier change control process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications. Lead component controls-related process improvements (qualifications, control plans, receiving inspection, etc.) in collaboration with key business partners and the supplier’s applicable functional groups. Own, drive, and lead the assigned Source Quality related projects, activities, initiatives with limited supervision. Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for assigned projects. Prepare Supplier Quality Agreements and drive discussion with supplier while consulting with Source Quality Management. Respond proactively to changing regulatory and business needs, including external standards. Lead component controls-related process improvements (qualifications, control plans, receiving inspection, etc.) in collaboration with key business partners and the supplier’s applicable functional groups. Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001). Qualifications Education: A minimum of a Bachelor's degree in Engineering, an Applied Science or a related technical and quality field is required. Required Skills & Experience: A minimum of 6 years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation Prior manufacturing, plant, or technical background Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production, and process controls Significant experience with documentation and technical writing skills, in a regulated compliance environment Demonstrated ability to identify compliance risks and assess business impact 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) Ability to manage complexity and lead a diverse team Must have strong business acumen The ability to collaborate with all levels of management in cross-functional team environment Ability to communicate effectively in English Preferred Skills & Experience: Working experience in good manufacturing practice regulated environment (medical device, pharmaceutical, etc.) Demonstrated knowledge of manufacturing principles and practices, and procedures Direct experience in plant and/or supplier GMP auditing Component Qualification/Process Validation experience New product introduction experience Prior experience with FDA inspections Broad knowledge of Quality System Regulations and Supplier Quality Management principles Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches Working knowledge of Quality issue investigation, Non-Conformance Reports (NCRs), Corrective and Preventative Actions (CAPAs) ASQ Certifications for Certified Quality Engineer (CQE), Quality Manager (CQM), and/or Supplier Quality Professional (CSQP) Quality Auditor qualifications or Lead Auditor certifications such as ASQ Certified Quality Auditor (CQA) or Biomedical Auditor (CBA) Flawless Project Execution (FPX) or Project Management Professional (PMP) trained and certified Six Sigma Black Belt/ Green Belt (CSSBB)/CSSGB) or Lean certification from a recognized program or PE leadership training 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®) Bilingual in English and other language (Spanish, German, Portuguese, or Mandarin) Other: This position will require up to 35% domestic and international travel. Position based in one of the following MedTech J&J sites in Somerville, NJ; Guaynabo, Puerto Rico; West Chester, PA; Cincinnati, OH; Raynham, MA; Warsaw, IN). At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Ohio-Cincinnati-4545 Creek Road Other Locations North America-United States-Puerto Rico-Guaynabo, North America-United States-Massachusetts-Raynham, North America-United States-Indiana-Warsaw, North America-United States-Pennsylvania-West Chester, North America-United States, North America-United States-New Jersey-Somerville Organization Ethicon Endo Surgery Inc (6041) Job Function Engineering Requisition ID 2206049115W