Senior. Quality Source Engineer

The Site Senior Quality Source Engineer (fixed term) serves as the on-site Johnson & Johnson Medical Devices (JJMD, hereafter represented by Synthes GmbH and Medos International SARL) quality engineering representative for the Strategic Collaborator (SC). In collaboration with the SC, he/she utilizes quality engineering principles and problem-solving skills to improve and maintain JJMD products and processes. He/she supports the SC quality engineering team on initiatives impacting JJMD products and processes, by providing guidance in validation, risk management, product quality issue resolution and escalation, and quality systems performance monitoring. The Senior Quality Source Engineer is responsible for ensuring that the SC has a clear understanding and ability to execute to the JJMD/SC Quality Agreement requirements, J&J Policies, and applicable regulations and standards. Position duties and responsibilities • Reviews and approves key quality records related to JJMD products in accordance to the Quality Agreement (QA) and Quality System Execution Plan (QSEP) as per Change Control process. • Coordinates JJMD review of Non-routine Rework and Use-As-Is nonconformance disposition in collaboration with other required JJMD functions. Reviews high-risk CAPAs (i.e. Field Action, Critical Audit Observations, Major External Audit Observations, Near Misses and PRM). • Partners with the SC to assess nonconformances resulting from the Product Release Monitoring (PRM) process. • Approves nonconformance investigations resulting from PRM process. • Track & Trends PRM data and communicates any negative trend to the JJMD and SC Quality Management. • Supports SC Quality and Manufacturing Engineering on the resolution of quality issues impacting JJMD products and coordinates additional subject matter expert support needed from JJMD. • Supports improvement plans to address below-target metrics and negative trends. • Partners with SC on Recall Prevention. • Supports SC on External Audit Readiness initiatives. Supports the execution of the PRM process, as needed. • Supports New Product Introductions and Product Transfers to the Strategic Collaborator site Qualifications A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Further Education (if applicable): • N/A Experience: • Experience working in both an FDA and European regulatory environment is preferred. • This position will require relevant experience working in manufacturing/operations. • In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. • Experience with a proven track record of implementing appropriate risk mitigation. • Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. • Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making. • The ability to perform