Ethicon LLC , a member of Johnson & Johnsons Family of Companies is recruiting for a Process Quality Leader at San Lorenzo, PR!

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.

The Process Quality Leader provide technical leadership towards the identification of the causes for non-conformances and process' failures, and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Ethicon's QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process.

Key Responsibilities:

• Review and analyze the quality trends with the manufacturing team.
• Provide mentorship to manufacturing supervisors to ensure that effective in-depth investigations are performed.
• Provide leadership and mentorship to multi-functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented.
• Own the investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, to facilitate the implementation process.
• Writes procedures, protocols and any other Documentation needed for the improvement of processes and systems.
• Provides training and education to the manufacturing team on tools for process evaluation and improvement. (Analytical trouble shooting, FMEA, statistical concept application and QSR/ISO requirements).
• Lead a number of CAPA and recommend CAPA’s based on negative trends.
• Handle, prepare the data and present product issue investigations (PRE’s), near misses and QRB.
• Follow all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001)

Qualifications

Education:

• A minimum of a Bachelor's Degree is required. Focus degree in Engineering or Science is preferred.
• Master’s Degree is preferred.

Experience and Skills:

Required:

• A minimum of six (6) years of related work experience.
• Previous experience with QSR/ISO.
• Advanced computer skills (Microsoft Office) and use of software application(s).
• Knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques.
• Proficient in the preparation of technical reports and presentations.
• Bilingual (Spanish & English).

Preferred:

• Previous experience in quality role within the manufacturing and/or a medical device industry.
• Leadership skills, collaboration, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.
• Good negotiation skills. Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland.

Other:

• Available to travel up to 10% of time is required.
• Able to work/visit all three shifts of the operation and working irregular hours.

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 .