Quality Engineering

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: San Lorenzo, Puerto Rico, United States of America Job Description: Johnson & Johnson is currently recruiting for a Quality Engineer! This position will be located in San Lorenzo, PR.

Summary: Reports to Quality Operations Lead, Quality Operations Leader or designee and with the objective of maintaining high-quality standards for the product manufacturing process and the compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations and Quality Assurance during the design, development, enhancement, revision and implementation of the quality systems for the efficient manufacturing of products and processes. Provide support and expertise on problem solving, process improvements and in the usage of quality tools. Ensure compliance with company policies and procedures such as Design Control, Process Validation, Test Method Validation, and Sampling Plan Development and Review. Generates quality indicators and supports nonconformance investigation and corrective action implementation at the business unit level and/or Plant level.

Supports Internal Compliance Function as required (QSR/ISO training, internal and external audits, trends analysis, etc.). Ensures compliance of areas of responsibility with the department, company, OSHA, ISO and QSR concerning safety, good housekeeping practices and manufacturing practices. Supports Operations in the generation of quality indicators, evaluation and implementation of action plans to eliminate root causes of non-conformances and in the development and execution of strategic and tactical plans to run base business. Lead and/or support Plant Initiatives and/or special projects. Supports/initiates investigations of non-conformances (such as but not limited to NCR, CAPA, Audit Observations), and initiates and maintains interplant communications of quality issues. Applies Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to the improvement of products or processes and in solving process/product-related problems. Promotes and applies Process Excellence Methodology to improve products/processes/systems. Supports validations as required. Performs other tasks as assigned by the Quality Operations Lead, Quality Operations Leader or and/or Site Quality Lead. Develop, write and approve as required policies, procedures, test methods, specifications. Support the Plant Sterilization processes. Provide expertise in the design, development, and implementation of suitable quality systems for new or existing products & processes. Facilitate the design transfer process between corporate and plant environments. Conduct internal audits and external (supplier, contractor, contract laboratory) audits, in QSR’s and ISO9000, as well as assessments of technical, engineering, operations, & quality related areas. Approve and support the control and disposition of non-conformance