NeuWave Medical, Inc., part of the Johnson & Johnson Family of Companies, is recruiting for a Staff Quality Engineer.
The Ethicon Surgical Care business is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Biosurgery, Ethicon Energy, Ethicon Endomechanics, Ethicon Robotics, Megadyne, NeuWave, and Torax. With annual sales of $11 billion, the Global Surgery Group is the world’s largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.
The Ethicon Surgical Care 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 Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, 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. 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.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!
- This Quality Engineer is the Subject Matter Expert in the Neuwave quality system.
- Provide training regarding Quality Management System Elements (including, but not limited to CAPA, NC, DRB, Management Review, Quality Planning, Quality Manuals & Metrics) to representatives from other functional areas.
- Monitor and report Quality Management System metrics.
- Works on complex investigations, coordinates technical teams and leads multi-functional teams.
- Finds opportunities to continuously improve quality systems and processes in ·alignment with overall quality and business objectives.
- Supports, participates, and leads in multi-functional projects when assigned/appropriate.
- Provide audit support for 3rd Party Inspections (e.g. Registrar, Notified Body, FDA, or customer audits).
- Processes document changes in applicable document management systems as needed including maintenance of Franchise Quality Manuals and Quality Planning procedures.
- Provide leadership on optimization and harmonization Quality projects across Ethicon.
- A minimum of a Bachelor's Degree is required. Focus Degree in Engineering, Sciences, or Business Analysis is preferred.
Experience and Skills:
- A minimum of six (6) years of relevant work experience
- Experience working in an FDA regulated environment
- Experience working in an Operations, Manufacturing, Quality and/or Engineering role
- Experience in dealing with audits/ inspections with the FDA, other notified bodies or any other Health Authority
- Strong communication, problem solving and analytical skills
- Strong in ability to build collaboration, partnership and teamwork across local and global organizations
- Leadership skills without direct authority responsibility
- Project Management skills with a strong results orientation
- This position may require up to 10% domestic and international travel
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .