Johnson & Johnson Careers
Requisition ID: 2649180619
NeuWave Medical, a division of Ethicon US, LLC, is seeking a Quality Engineer located in Madison, WI.
NeuWave Medical specializes in developing and commercializing energy-based minimally invasive medical devices. These devices must deliver improved healthcare economics and a better experience for patients in terms of outcomes or quality of life.
NeuWave Medical, Inc. was established in a collaboration with the University of Wisconsin - Madison. NeuWave arose as the result of an academic collaboration between engineers and physicians who wished to improve their ability to treat cancer and other important clinical problems. As a result, NeuWave is highly focused on solving real clinical problems in a manner that will directly benefit patients by being more effective, minimally invasive, and cost conscious. Everything that we do is based on providing better technology for patients, physicians, and healthcare organizations.
The role of a quality engineer at Ethicon is to apply the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo:
- Meet and exceed the expectations of our customers
- Achieve and maintain compliance with regulatory expectations
In order to support business objectives, a successful quality engineer will have orientation to the big picture and attention to detail.
The role of a quality engineer is important to the success of the business. The successful engineer will partner with new product development or supply chain to achieve business goals in a manner that complies with regulatory expectations and the J&J Credo. Examples of leadership behavior in previous work roles or military experience are preferred.
The quality engineer must have the ability to understand customer requirements and be able to help the organization translate them into engineering requirements or business process steps. The quality engineer must have the ability to translate statistics and the outcome of statistical tests into actions for the team and business. Examples of technical communications and achieving organizational alignment are preferred.
- Depending on job needs, a quality engineer will support quality engineering and compliance in:
- New product development / new product introduction / new process introduction
- Supply chain (life cycle engineering, manufacturing, assembly, or supplier quality) Quality systems
- Begin to employ key company processes to support projects and quality system processes as required by the position:
- Follow quality procedures and add to the quality system documentation. Understand expected outcomes of key quality processes.
- Create or update risk documents.
- Demonstrate growing proficiency in applying various tools and methods in support of new product introduction, production, and support of business processes. For example:
- Risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure modes and effects analysis).
- Reliability assessments of product design
- Root cause investigations using various problem solving techniques and tools, and assesses effectiveness of corrective actions.
- Develop test methods in equipment, process, and product qualifications/validations. Executing methods as needed for development and qualification. Perform Measurement Systems Analysis (MSA).
- Ensure that process Quality control plans are in accordance with product or process risk level and are consistently followed.
- Implement and/or maintaining production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).
- A bachelor’s degree and a minimum of 2 years of related experience is required.
- A technical degree engineering or science field and/or an advanced degree is preferred.
- Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred.
- Certified Quality Engineer from ASQ is preferred.
- A green belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferred.
- Knowledge of statistical applications for example DOE’s, capability studies, T test, etc. is preferred.
- Knowledge of design control is preferred.
- Knowledge of GDP and GMP are preferred.
- Knowledge of Root cause analysis and Corrective Action / Preventive Action (CAPA) expectations is preferred
- Knowledge of reliability testing and analysis is preferred.
- The ability to work in a team environment is required.
- Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software are required.
- This position will be located in Madison, WI and may require up to 20% domestic travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
NeuWave Medical, Inc. (6229)