J&J Family of Companies Hiring for Staff Quality Engineer at United States Full Time

Ethicon Endo Surgery Inc., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Staff Quality Engineer to based at one of the Johnson & Johnson campuses in the United States.

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com

Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

Our Staff Quality Engineer is responsible for applying 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; and achieve and maintain compliance with regulatory expectations. To support business objectives, a successful Quality Engineer will have orientation to the big picture and attention to detail. Are you interested in joining a team that is developing the next generation of innovative devices that serve our surgeons and patients? Apply today!

Key Responsibilities:

• Employ leadership principles and continue to hone skills through observation and contribution on tasks.

• Practice technical and business communication skills by learning key project / product / medical terminology as well as statistical terms and voice of the customer.

• Support quality engineering and compliance in: New product development / introduction and/or new process introduction; Lifecycle Engineering, and Quality Systems.

• Employ key company processes to support projects and quality system processes as required by the position, including following quality procedures and add to the quality system documentation, understanding expected outcomes of key quality processes, and creating or updating risk documents.

• Utilize Risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure modes and effects analysis).

• Conduct reliability assessments of product design.

• Perform root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.

• Develop and validate test methods in equipment, process, and product qualifications/validations. Design and execute Measurement Systems Analysis (MSA).

• Implement and/or maintaining production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).

Qualifications

Education:

• A minimum Bachelor’s degree required in Science, Engineering, Technology, or Math or another relevant field

  Required Experience & Skills:

• A minimum 6 years of relevant work experience

• Experience in a Quality role – with a preference in Electromechanical and or software driven applications

• Application of Design Control fundamentals

• Knowledge of applied statistics and experience with statistical software applications (e.g., Minitab and/or ReliaSoft)

• Knowledge of product/process Risk Management (DFMEA/PFMEA or Gage R&R Analysis, FDA, and ISO standards) and GMP

• Ability to identify and simplify complex issues, as well as demonstrated ability for proactive, organized, and systemic approach to making decisions and resolving issues

• Ability to work in a team and demonstrate good interpersonal, organization, and oral/written communication skills

  Preferred Experience & Skills:

• Experience in medical device or other highly regulated industry; military veteran leadership experience

• Familiarity with medical device regulations (FDA, EU-MDR, etc.)

• Quality Engineering Certification (e.g., ASQ CQE)

• Certification (e.g., Black belt) in one or more of the Process Excellence roadmaps (e.g., DMADVV, DMAIC, or Lean)

  Other:

• The role will be based at one of the Johnson & Johnson campuses in the United States

• Requires up to 10% travel, domestic and international

  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.

Primary Location

United States-Ohio-Cincinnati-4545 Creek Road

Other Locations

North America-United States

Organization

Ethicon Endo Surgery Inc (6041)

Job Function

Engineering

Requisition ID

2105953444W