Staff Quality Engineer, New Product Introduction

Employer: Mentor Worldwide LLC

Job Title: Staff Quality Engineer, New Product Introduction

Job Code: A011.4729

Job Location: Irving, TX

Job Type: Full-Time

Job Duties: Function as the Quality representative in new product development and lead in efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and statistical process control.

Provide quality oversight for new product development and design change process.

Provide subject matter expertise for risk management processes per all applicable regulatory requirements.

Utilize Quality Engineering tools and practices for the effective and efficient development, transfer, and maintenance of products and processes throughout the product lifecycle.

Improve and maintain products and processes that are aligned with overall Quality and Business vision.

Utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.

Develop a comprehensive risk management plan and ensure the delivery and utilization of effective quality strategies through all aspects of Design Control and Life Cycle Management of the product.

Ensure compliance with company policies and procedures while providing mentorship in the implementation of regulatory requirements (e.g.

Quality System Regulation, EU MDD, ISO standards, etc.).

Assist the team to ensure the application of design controls and product risk management as well as the investigation/correction of design failures/challenges and effective design control and transfer.

Collaborate with Manufacturing Quality Engineering to implement and supervise process capability measures prior to Design transfer.

Provide Lifecycle Management Support by providing accurate review and direction during change control and continuous improvement activities for changes that could affect the product design (form, fit, function, and labeling requirements).

Ensure consistent application of Quality Engineering, Process Excellence/Six Sigma tools and techniques, including active and detailed investigation of quality issues and effective corrective/preventative action.

Up to 30% domestic travel required.

Requirements: Employer will accept a Master's degree in Industrial, Validation, or Mechanical Engineering, or related field and 3 years of experience in the job offered or in a Staff Quality Engineer New Product Introduction-related occupation .

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Johnson and Johnson is committed to providing interview process that are inclusive of our applicants' needs.

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