Staff Quality Engineer Job – Johnson & Johnson – Piscataway, NJ, USA
Johnson & Johnson, through its operating companies, is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
The Quality Engineer North America Customer Logistics & Services Quality & Compliance (CLS Q&C) supports North America strategy development for the CLS North America Distribution network and CLS Transportation group. This individual will be accountable for the development, oversight and execution of quality and compliance engineering and validation programs, facility and technology transfers and integration/divestitures to meet customer and business needs in compliance with regulatory requirements, Enterprise Standards, Quality Management Systems at Distribution Centers in North America.
He/she will serve as a single point of contact to CLS Quality and Compliance, CLS Operations, CLS Engineering, Information Technology (IT), Centers of Excellence (COE’s) and Project Management Organization (PMO’s) in the US and Canada on Distribution and Transportation Quality Engineering related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues associated with Distribution and Transportation. He/she defines, implements, and validates quality requirements and systems in alignment with departmental strategies and serves as the business expert on Quality Engineering for Distribution and Transportation Services. In collaboration with key business partners, he/she will identify opportunities to continuously improve quality, cost and time factors, consistent with both Sector and CLS business objectives. Identifies significant business issues, prioritize for action, and leads improvement opportunities and problem solutions.
Responsible for establishing and validating improvements to systems and process that support: Warehouse Management Systems (SAP), Quality Management Systems and Software systems ; CAPA, Non-conformance, Change Control, Document Management, Training, Metrics Reporting, Trending and Statistics, Calibration, Preventive Maintenance and Audit (internal and external) process. The development and implementation of cold chain and temperature controlled ambient solutions and validation protocols in distribution and transportation. Additional responsibilities include participating and leading investigations, remediation activities, standards development and implementation, audit and training, identifying preventive opportunities to continuously improve quality, cost and time factors and understanding current and emerging regulations and their impact to quality distribution and transportation practices. He/she will report to the Director, Quality Execution, North America CLS Q&C.
A Bachelor’s degree in engineering, scientific, technical scientific, or Quality Regulatory Compliance disciplines and a minimum of 8 years of regulated healthcare industry experience in distribution, transportation, temperature control, manufacturing, operations, regulatory and/or quality compliance is required. Prior experience in an engineering role and experience working with an indirect organization that delivers results is required. Proven success in developing a global and regional strategy with financial, quality and cycle time results is preferred. Understands the linkages in quality and regulatory compliance from product development through manufacturing and delivery to customer and health authority is preferred. Builds consensus, can lead individuals through change and has strong project management experience is required. Strong problem solving, decision-making, and root cause analysis skills is required. Six Sigma, Lean, 5S or ASQ Certification and trainings are an asset. Must have excellent communication skills, and strong collaboration and influence skills to partner effectively across functions and operating units is required. Makes the complex clear and easily understood by others. Flexible with ability to work independently and on teams and has excellent time management skills to handle multiple projects and deadlines. Strong knowledge of FDA 21 CFR Part 210, 211 and 820 and ISO 13485 and SAP, ERP systems are requirements.
The primary locations for this position are Somerset, NJ , Skillman, NJ or Piscataway, NJ. Approximately 40% travel within region is required.
Primary Location: North America-United States-New Jersey-Piscataway
Organization: Johnson & Johnson HCS Inc. (6077)
Job Function: Quality (Eng)