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Staff Quality Engineer
Requisition ID: 2506180201
NeuWave Medical, a division of Ethicon US, LLC, is seeking a Staff Quality Engineer located in Madison, WI.
NeuWave Medical specializes in developing and commercializing energy based, minimally invasive medical devices. We are an innovative growth company with a passion for clinical relevant, physician friendly technology and a commitment to improving patient outcomes.
- Apply advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments. Plans and conducts projects with moderate to high technical responsibility, complexity, or strategic input. Receives summary instructions from technical Quality leaders at various levels, in addition to other functional stakeholders.
- Support the application of quality engineering and quality compliance in support of demanding projects. Be involved with Quality Systems initiatives as a primary assignment or additional assignment. Have more advanced understanding of the expected output of quality processes and be able to assess the adequacy of objective evidence
- New Product or process Introduction
- Business improvement
- Life Cycle Engineering
- Operate more independently and will generally mentor or coach less experienced QEs.
- Demonstrate strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.
- Lead and/or contribute to the utilization of various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode and effects analysis).
- Lead or contribute to the reliability assessments of product design.
- Lead and/or contribute to root cause investigations using various problem solving techniques and tools (Ex. K-T analysis), and assesses effectiveness of corrective actions.
- Conduct and support the development of, test methods in equipment, process, and product qualifications/validations.
- Develop, implement, and/or maintain process Quality control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed.
- Develop, implement, and/or maintain production and process controls using appropriate techniques and tools (for example, advanced process monitoring and control tools, methods of statistical process control, process performance metrics). Perform or guide Measurement Systems Analysis (MSA).
- Mentor others in various technical capabilities.
- Interpret standard and non-standard sampling plans.
- Participate in technical reviews as appropriate.
- Support execution of strategic vision or plan by collaborating with other quality leaders to identify required Quality Engineering skills and competencies.
- A Bachelor’s degree is required and a minimum of 6 years of relevant work 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.
- Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software are required.
- Strong technical understanding of manufacturing equipment and processes is required.
- Certifications - Certified Quality Engineer from ASQ is expected. Additional certifications are preferred.
- Experience implementing appropriate risk mitigation with knowledge of product or process and process Risk Management (FDA & ISO standards) is required.
- Experience with Design control, GDP, GMP and organizational requirements are required.
- Experience with Root cause analysis and Corrective Action / Preventive Action (CAPA) expectations is required.
- Plan and perform basic reliability testing and analysis is required.
- Experience managing projects and demonstrating project leadership abilities is required.
- Advanced knowledge of Quality Engineering/Scientific Method techniques and principles. Applied statistics of increasing complexity is preferred.
- This position will be located in Madison, WI and may require up to 15% domestic and/or international 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)