DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own. Johnson & Johnson Customer & Logistics Services (CLS) is a global Supply Chain organization that supports operating units across all of the Johnson & Johnson Family of Companies.
CLS strives to deliver an exceptional customer experience through leading critical customer facing-functions such as distribution and transportation. In addition, CLS oversees critical business enablers, including how we gather and manage supply chain master data, safe and secure supply chain practices, product identification standards, and market/channel access capabilities. CLS supports all three sectors of Johnson & Johnson: Medical Device & Diagnostics, Pharmaceutical, and Consumer Products. This team is represented in multiple countries, and continues to grow globally in both visibility and responsibility. The CLS team reports to Johnson & Johnson Supply Chain and partners closely with groups throughout the supply chain organization.
DePuy Synthes is currently recruiting for a Staff Quality Engineer to be located in the United States to support Johnson & Johnson Customer & Logistics Services (CLS) initiatives. The position can be located at a CLS (Customer & Logistics), DePuy Synthes (DPS) or other J&J or be located remote from an existing site.
The Staff Quality Engineer is responsible for the implementation and supervision of Quality and Compliance programs for the DePuy/Synthes Forward Stocking Locations (FSL) and Third Party Logistics (3PL) sites. This position serves as a liaison with Quality and Supply Chain partners, and the CLS Leads on Distribution Quality related matters, and collaborates with the DePuy/Synthes and CLS organizations to drive timely resolution of Quality related issues. This position identifies opportunities to continuously improve quality and compliance consistent with Enterprise, Sector and CLS business objectives. The Staff Quality and Compliance Specialist provides proposals and coordinates quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through work stream groups.
• Design and execute a Quality System for the Forward Stocking Locations(FSL)
• Prepare, facilitate and conduct Internal Quality Audits of the FSLs and 3PLs including identification of issues and recommendation and implementation of appropriate actions
• Support all internal (JJRC) and external Health Authority inspections
• Ensure the Quality program maintains regulatory compliance
• Coordinate and assist in maintaining current state licensure and registrations for the FSLs
• Make proposals and assist in the development of corrective action plans and monitor implementation including follow-up on closure of corrective and preventive actions(CAPA)
• Conduct investigations, collect data, analyze trends and prepare reports for assigned quality processes
• Management of the quality aspects of inventory processing, including kit/lot reconciliation within the FSL/3PLs
• Assist in the development, implementation and review of standard operating procedures for interactions with contract distribution providers
• Provide quality support for technology transfer and improvement of existing distribution processes
• Support training efforts related to SOPs and system related training
• Lead cross-functional teams to identify and correct distribution related issuesQualifications
• Bachelor’s degree in a technical or scientific discipline is required; in an engineering discipline is preferred. A minimum of least six years of directly relatable experience in an FDA regulated environment. As a minimum, six years of experience in Supply Chain, Quality Assurance or Engineering, or Regulatory Compliance.
• Experience in the development and deployment of a Quality System is preferred
• Business experience in regulated industry in a fast paced, dynamic, global operation is required, while experience in health care industry
• Medical device loaner kit operations is preferred
• Experience within a diverse organization and a Process Excellence Belt is preferred
• Must be able to actively conduct site assessments and develop action plans to drive improvements accordingly
• Must be able to develop and administer a strategic audit plan for the FSLs/3PLs that optimizes compliance and minimizes customer risk
• Project management, change management, knowledge management, and technology and data management experience are strong preferences
• This position may be remote or located at any CLS and DPS site, within J&J. This position will also require up to 50% of domestic travelPrimary Location
United States-Massachusetts-RaynhamOther Locations
North America-United States-California-Los Angeles, North America-United States-Arizona-PhoenixOrganization
Johnson & Johnson HCS Inc. (6077)Job Function
Quality (Eng)Requisition ID
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