Ethicon, of the Johnson & Johnson's Family of Companies, is recruiting for a Source Quality Engineer to be located in Guaynabo, PR.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Supplier Quality Engineer will be responsible for external suppliers of direct materials 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 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.
You will:
• 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 Approved Supplier List management.
• Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management. May lead this process under the guidance of Supplier 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.
• Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
• Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.
• Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Actively participates in discussions to drive resolution.
• Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.
Qualifications
• A minimum of a Bachelor's degree in Engineering is required.
• A minimum of two (2) years of related experience in Operations, Engineering, Quality Engineering or Quality Assurance is required. Previous experience as COOP/Intern will be considered.
• Prior manufacturing, plant or technical background is preferred.
• Knowledge of good manufacturing practices in a regulated environment is highly preferred (medical device, pharmaceutical, etc.).
• Demonstrated knowledge of manufacturing principles, practices, and procedures is preferred.
• Basic knowledge in plant and/or supplier GMP auditing is preferred.
• Experience with documentation and technical writing skills, in a regulated compliance environment, is preferred.
• Basic knowledge of Quality System Regulations is desired.
• Ability to manage complexity and work in a diverse team environment is essential.
• Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required. Experience with Minitab, Visio, and Microsoft Project is preferred.
• Bilingual in English and other language (Spanish, German, Portuguese, or Mandarin) is required.
• This position may require up to 15% domestic and international travel.
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-Puerto Rico-Guaynabo- Organization
Ethicon Endo Surgery, LLC (7597)
Job Function
Quality (Eng)
Requisition ID
1203191203
