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Staff Supplier Quality Engineer
Somerville, New Jersey; United States; San Angelo, Texas; Irving, Texas; Athens, Georgia; Guaynabo, Puerto Rico; San Lorenzo, Puerto Rico; Cornelia, Georgia
Requisition ID: 4981180304
Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Supplier Quality Engineer. This role can be in based in any U.S. Ethicon based location including Cornelia, GA; Athens, GA; San Angelo, TX; Irving, TX; San Lorenzo, PR; Guaynabo, PR with a preference for Somerville, NJ.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading 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 safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
You, the Staff Supplier Quality Engineer will be responsible for external suppliers of raw materials and finished goods for the Ethicon franchise. He/she leads the deployment of the Supplier Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for direct material suppliers of the Ethicon Supply Chain.
This individual will actively leverage talents and lead teams (SQEs and others), collaborate with Strategic Sourcing, R&D, Engineering, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve suppliers’ Quality, service and performance. In this role, the individual leads the development and execution of plans/strategies, and implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regard to the determination, selection, qualification, monitoring, and disengagement of suppliers. He/she proactively identifies, develops, and leads the investigation and resolution of supplier-related challenges, and implements appropriate Quality Engineering methodologies, 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, material upgrades, 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.
- Provide timely business support for the assigned Ethicon Supplier Quality Management (SQM) function globally
- Lead, develop, and implement supplier/purchasing controls and associated activities including ASL management
- Participate in and/or lead the identification, selection, qualification, monitoring, and disengagement of suppliers for SQM
- Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems
- Partner with Procurement/Sourcing, R&D, Engineering, 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
- Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and closure communication including ASL updates and material/supplier qualifications
- Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision
- Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects
- Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements
- Identify business opportunities for and lead the preparation/management of Supplier Quality Agreements (SQA)Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts
- Ensure alignment of SQM Quality Systems with current regulatory requirements, industry trends, J&J standards, policies, procedures, and work instructions
- Lead and provide SQM support for appropriate site Quality and Compliance audits related to supplier/purchasing controls
• A minimum of a Bachelor's degree is required. A technical/scientific discipline is required; a degree in Engineering preferred
• A minimum of 5 years of Quality/ Engineering work experience is required.
• Working experience in a highly regulated environment (medical device, pharmaceutical, etc.) is preferred
• Practical experience with GMP documentation and writing skills in the FDA regulated environment is required
• Broad experience with GxP Quality Systems, including but not limited to investigations, qualification/validation, CAPA, Supplier/Purchasing Controls, SQA, material/production/process controls, and supplier certification is strongly preferred
• Working experience with Medical Device-associated materials such as chemicals, packaging, textiles, etc is preferred
• Working experience with External Manufacturing and Contract Laboratories is preferred
• Demonstrated practical knowledge and skills in and application of SQM, QSRs, and ISO13485 are highly desirable
• Professional Certification, training, or working knowledge/skills in Project Management/FPX is strongly preferred
• Professional Certifications: ASQ CQE, CSQP, CMQ/OE, CSSGB, CSSBB, and/or CQA strongly preferred
• Process Excellence Certification (J&J Six-Sigma/Lean Green Belt/Black Belt) is preferred
• Working knowledge of Quality Risk Management tools (e.g. ISO 14971, FMEA/FMECA/FTA/HACCP, etc.) preferred
• Familiarity with material/component/process/equipment qualifications and validations is desirable
• Demonstrated strong organizational, interpersonal, influencing, communication, and leadership skills are an asset
• Computer Skills (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project®) is preferred
• This role can be in based in any U.S. Ethicon based location including Cornelia, GA; Athens, GA; San Angelo, TX; Irving, TX; San Lorenzo, PR; Guaynabo, PR with a preference for Somerville, NJ. It will require travel up to 35% internationally & domestically travel depending on location.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Somerville
North America-United States-Puerto Rico-Guaynabo, North America-United States-Georgia-Cornelia, North America-United States-Puerto Rico-San Lorenzo, North America-United States, North America-United States-Texas-San Angelo, North America-United States-Texas-Irving, North America-United States-Georgia-Athens
Ethicon Inc. (6045)