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STAFF SOURCE QUALITY ENGINEER
The Site Staff Quality Source Engineer serves as the on-site Johnson & Johnson Medical Devices 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, including validation, risk management, product quality issue resolution and escalation, and quality systems performance monitoring. The Staff 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.
Tasks & 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.
- May serve as the deputy of the (Senior) Quality Source Manager
- A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
- Quality Engineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.).
- 4/6 years of related experience is preferred.
- 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 "hands on" troubleshooting and problem solving is required.
- Good technical understanding of manufacturing equipment and processes is required.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations 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.
- Fluent in English, Good French.
Medos International Sarl (7898)