Process Quality Leader

Ethicon, a member of Johnson & Johnson's family of Companies, is recruiting for Process Quality Leader.

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.

Are you interested in making a difference in a thriving diverse company culture, that celebrates the uniqueness of our employees and is committed to inclusion? Apply today for this exciting opportunity!

In this role the Process Quality Leader under the direction of the Business Unit Manager, provides 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.

You will:

• Dedicated to develop, manufacture, and market quality products and to promote a quality Under the direction of the Business Unit Manager, the PQL provides 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.

• Reviews and analyses quality trends with the manufacturing team. Considering the quality trends provides direction in terms of setting work priorities for process enhancement.

• Provides guidance to manufacturing supervisors to ensure that effective in-depth investigations are performed.

• Provides leadership and guidance to cross functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented. Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.

• Leads investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, facilities the implementation process.

• Analysis of data and based on the trends recommends actions for process, equipment and system improvement.

• Writes procedures, protocols and any other Documentation needed for the enhancement of processes and systems.

• Provides training and education to the manufacturing team on tools for process evaluation and enhancement. (Analytical trouble shooting, FMEA, statistical concept application and QSR/ISO requirements)

• May lead a number of CAPA and should recommend CAPA's based on negative trends.

• Handles, prepares data and present product escalation investigations (PRE's), near misses and QRB.

• Leads in-process investigations with a multifunction team to determine root causes and provides recommendations for corrections on preventive actions.

• Handles preliminary investigations of product complaints, analysis, trends and recommendations or leads corrective/preventive actions.

• Provides technical supervision to multilevel, cross functional teams. Provides supervision to technical professionals such as Process Quality Technicians, College Recruits, Coops or Supervisors that are assigned to work on projects related to process enhancement initiatives.