J&J Family of Companies Senior Quality Engineer, New Product Development in Somerville, New Jersey
The Ethicon business offers a broad range of products, platforms and technologies including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Based in Somerville, New Jersey, Ethicon Inc. was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery Inc., which was created 20 years ago, in Cincinnati, Ohio, develops innovative devices that have driven the revolutionary shift from open to minimally invasive surgery and continues to lead this industry today.
Duties & Responsibilities
The Senior Quality Engineer will partner with R&D and Operations, utilizing various Quality Engineering tools, in the development and manufacture of innovative new products, as well the maintenance of current products, materials and processes.
• Support multi-functional product development teams in matters related to Quality Engineering
• Responsible for developing comprehensive quality strategies
• Lead the development of comprehensive risk documentation for the product and process, including overall risk management plans and reports
• Ensure effective and efficient use of Quality Engineering techniques, such as risk analysis, statistical data analysis and the development of sampling plans and rationale
• Ensure the development and validation of appropriate test methods for the design and manufacture of products and components.
• Support design control and process validation activities
• Assist in root cause investigation of quality issues and implementation of effective corrective and/or preventive action(s).
• Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures, as well as medical device regulations
• Identify areas of opportunity for improving customer experiences through the evaluation of available post-market customer data
• Bachelors of Science in Chemistry, Biology or Engineering discipline
• Minimum of Five (5) years of work experience in an FDA regulated industry
o Medical Devices, Biologics or Pharmaceuticals
o Minimum of Three (3) years of experience with a Master’s Degree or One (1) year with a PhD
• Basic knowledge of 21 CFR Part 820, ISO 14971 and ISO 13485
• Basic to Intermediate knowledge in Statistics, Design Control, Risk Assessments and Process Validation
• Demonstrated root cause and problem solving skills
• Understanding of Six Sigma and Process Excellence tools and methodologies
• Experience in authoring Risk Assessments; to include Hazard Analysis, Design, Application and Process FMEAs and overall Risk Management Plans and Reports
• Demonstrated verbal and written communication skills; ability to effectively communicate with internal and external customers
• Strong interpersonal skills; comfortable with conflict management and collaboration
• Equally effective functioning independently or in a team environment
• Proficiency with quality-related applications such as Minitab
• Basic to Intermediate knowledge and familiarity of MICROSOFT applications (Excel, Word and PowerPoint)
• ASQ certification (CQE, CQM, CRE or CQA) preferred
• Familiarity with 21 CFR Part 4 (Regulation of Combination Products)
• Process Excellence (Green Belt, Black Belt, etc.) certification is highly desired.
LOCATION & TRAVEL REQUIREMENTS
• Position location: Somerville, New Jersey
• This position may require up to 20% travel: Domestic (US) and International
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
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.
United States-New Jersey-Somerville
Ethicon Inc. (6045)