Staff Supplier Quality Engineer

Job description

Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Supplier Quality Engineer. This role can be based in any Ethicon location including Athens, GA; Cornelia, GA; San Angelo, TX; San Lorenzo, PR; Guaynabo, PR; Juarez, Mexico; Somerville, NJ; with a preference for Neuchatel and Zug, Switzerland; and Norderstedt, Germany.

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 suppliers for the Ethicon franchise. She or he leads the deployment of the Supplier Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the Ethicon Supply Chain.

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 solutions and improve suppliers' Quality and overall 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 regards to the determination, selection, qualification, monitoring, and disengagement of suppliers. S/he 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, 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.

Key Responsibilities:
• Provide timely business support for the assigned Ethicon Supplier Quality Management (SQM) function globally
• Lead and provide SQM support for appropriate site Quality and Compliance audits related to supplier/purchasing controls; lead and support Purchasing Control Audit Readiness
• Ensure alignment of SQM Quality Systems with current regulatory requirements, industry trends, J&J standards, policies, procedures, and work instructions
• 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, 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
• 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

Desired profile

Qualifications :

• A minimum of a Bachelor's degree in a technical/scientific discipline is required; a degree in Engineering and Science preferred.
• A minimum of six (6) years of relevant professional business experience is required.
• A minimum of three (3) years of Quality/Engineering work experience is required.
• Practical experience with GMP documentation and writing skills in the FDA regulated environment is required.
• Working experience in a highly regulated environment (medical device, pharmaceutical, etc.) is preferred.
• Broad experience with GxP Quality Systems, including but not limited to investigations, qualification/validation, CAPA, NC, audit and Supplier/Purchasing Controls, and Supplier Quality Agreement is preferred.
• Working experience with suppliers (i.e., metals, plastics, packaging, chemicals, indirect, and/or external manufacturers) is preferred.
• Demonstrated practical knowledge and skills in and application of SQM, QSRs, and ISO13485 is preferred.
• Professional Certification, training, or working knowledge/skills in Project Management/FPX is preferred.
• Process Excellence Certification (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.) is preferred.
• Demonstrated strong organizational, interpersonal, influencing, communication, and leadership skills is preferred.
• Proficient Computer Skills in the following software (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project®) is preferred
• Fluent in German is preferred.
• This role can be based in any Ethicon location including Athens, GA; Cornelia, GA; San Angelo, TX; San Lorenzo, PR; Guaynabo, PR; Juarez, Mexico; Somerville, NJ; with a preference for Neuchatel and Zug, Switzerland; and Norderstedt, Germany. It may require up to 35% (international & domestic) 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.