Johnson & Johnson Careers
Associate Value Stream Quality Engineer
Requisition ID: 5446181025
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 1-2 years related experience.
Experience working in both an FDA and European regulatory environment is preferred.
This position will require relevant experience working in manufacturing/operations.
Knowledge of product/process Risk Management (FDA and ISO standards) is required.
Experience with implementation of risk mitigation is preferred.
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 preferred. The ability to think on the feet and providing sound judgment is highly desired.
Good technical understanding of manufacturing equipment and processes is required.
A thorough understanding of GMP/ISO regulations and validation regulations is preferred
This position may require up to 10% travel and will be based in an MD&D manufacturing facility.
Be VITAL in your career. Be seen for the TALENT you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Depuy Orthopaedics. Inc. (6029)