Principal Quality Engineer-2202140603
Description
Ethicon, Inc., a member of the Johnson & Johnson Family of Companies is currently recruiting for Principal Quality Engineer located in Cornelia, GA.
The Principal Quality Engineer will utilize Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle as detailed in matrix. This individual will utilize quality engineering principles and problem solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision. Ensure effective risk management to prevent unanticipated failure modes and ensure capability. Complete and maintain the Product Quality Plan to production equipment. Support plant safety through maintenance of electrical systems.
The Principal Quality Engineer will function as a project team member in matters relating to Quality Engineering. Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, statistical process control, and development of sample plans. Development of a comprehensive risk management plan for the product and process and effective quality strategies for validation. Develop and validate appropriate test methods for product and process performance. Ensure effective and consistent application of Quality Engineering and Process Excellence tools and techniques. Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action. Effectively utilize Process Excellence to solve problems and develop optimal products and processes. Ensure compliance with company policies and procedures. Provide guidance and recommendations involving the implementation of regulatory requirements (e.g. Quality System Regulations (QSR), Medical Device Directive (MDD), ISO standards, etc.).
The Principal Engineer will partner with Research and Development (R&D) to ensure the application of design controls and product risk management. Partner with R&D in the investigation/correction of design failures/challenges. Ensure effective design control and transfer. Partner with R&D in the development and conduct of the physical challenges associated with product performance. Assist R&D with new test method development and validation. Proactively communicate with QE’S product CTQs for process development/validation/control.
The Principal Engineer will partner with Engineering and Suppliers to ensure the application of process validation, process control, and process risk management. Partner with Engineering and Suppliers in the investigation/correction of process failures. Implement and monitor process capability for continuous improvement. Ensure effective change control. Proactively communicate any changes in design or changes in process that could affect product design. Develop systems to ensure quality of purchased raw materials and finished foods. Ensure supplier performance is monitored and addressed as needed. Provide leading metrics to Quality Assurance/Regulatory Affairs Business Unit Directors. Utilize technical skills specific to assigned commodities (e.g. sterilization, plastics, chemicals, etc.) to ensure adequate quality plans.
Qualifications
A minimum of a Bachelor's degree in Engineering, a Life Science, a Physical Science or a related technical discipline is required. Advanced degree (Master’s, PhD) preferred. A minimum of 10 years of engineering experience is required. Medical Device manufacturing experience is preferred. Experience working in a regulated industry is required. Knowledge of the following regulations and standards preferred: Quality Systems Regulations (QSRs), Medical Device Directive (MDD), Good Manufacturing Practices (GMPs), ISO 9001, 9002, 13485, 14971. Experience with Geometric Dimensioning and Tolerancing is preferred. Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required. Experience with Microsoft Project and Visio preferred. Knowledge of statistical software (i.e. Minitab, SAS) preferred. Knowledge of with statistics, sampling planning, risk assessment and process validation required. Knowledge of Process Excellence/Six Sigma tools and methodologies preferred. Knowledge of Lean Manufacturing is preferred. Process Excellence/Six Sigma (Green or Black Belt) Certification is preferred. Certified Quality Engineer (ASQ, CQE, CQM or equivalent) preferred. Must have excellent oral and written communication skills. Must have strong influencing skills. The ability to collaborate with all levels of management and influence decision-making in a cross-functional team environment is required. This position will require up to 30% domestic and international travel.
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Primary Location:North America-United States-Georgia-Cornelia
Organization: Ethicon Inc. (6045)
Relocation: Eligible No
Job Function: Quality (Eng)
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