J&J Family of Companies Senior Quality Source Engineer (m/w/d) in Umkirch, Germany
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 Senior Quality Source Engineer serves as the on-site Johnson & Johnson Medical Devices (JJMD) 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. 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.
Main Responsibilities & Duties:
Reviews and approves key quality records as they related to JJMD products.
Coordinates JJMD review and approval of Quality System documentation.
Supports Technical Assessments in collaboration with SC site compliance, JJMD Supplier Quality Compliance, and JJMD Product Management.
Partners with SC Quality Engineering, JJMD Medical Affairs, and JJMD R&D/PM in the development of Process Failure Mode Effects Analyses (pFMEAs) and corresponding Control Plans.
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 and External Audit Readiness initiatives.
A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. 4/‑6 years related experience preferred. Fluent in English and German.
Experience working in both an FDA and European regulatory environment is preferred. In-depth proven knowledge of product/process Risk Management (FDA and ISO standards) is required.
Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. knowledge of statistical Software use (MiniTab) is mandatory.
Good technical understanding of manufacturing equipment and processes is required.
Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
Advanced knowledge and proven leadership in the areas listed in the Major Responsibilities and Duties with the position.
Demonstrated project management and project leadership abilities are required. Quality Engineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.).
The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.
Synthes Umkirch (7127)