Quality Team Leader Jobs

Ethicon, a member of Johnson & Johnson's family of Companies, is recruiting for Quality Team Leader located in San Lorenzo, PR.

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 Quality Team Leader will be responsible of maintaining high quality standards for the product manufacturing process and the compliance with regulatory requirements, supervises day-to-day activities of the Quality Assurance Technicians, Finished Goods Quality Assurance Technicians, Raw Material Quality Technicians and/or Quality Assurance Laboratory Technicians, in accordance with QSR and Ethicon written specifications and quality standards. Generates quality indicators and supports nonconformance investigation and corrective action implementation at the business unit level and/or Plant level.

Responsibilities:

• Applies Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to the improvement of products or processes and in solving process/product-related problems. Promotes and applies Process Excellence Methodology to improve products/processes/systems. Supports validations as required.
• Lead and/or support Plant Initiatives and/or special projects.
• Supports Internal Compliance Function as required (QSR/ISO training, internal and external audits, trends analysis, etc.).
• Ensures compliance of areas of responsibility with the department, company, OSHA, ISO and QSR concerning safety, good housekeeping practices and manufacturing practices.
• Responsible for the coordination, maintenance and implementation of the Device Master Record.
• Participates in the interview and selection of qualified employees for authorized job openings.
• Supports/initiates investigations of non-conformances (such as but not limited to NCR, CAPA, Audit Observations), and initiates and maintains interplant communications of quality issues.
• Monitor the performance of the CME (Controlled Manufacturing Environment), including but not limited to Product Bioburden monitoring.
• Responsible for the evaluation and disposition of WIP and questionable raw materials by inspecting and testing as needed.
• Supports Operations in the generation of quality indicators, evaluation and implementation of action plans to eliminate root causes of non-conformances and in the development and execution of strategic and tactical plans to run base business.

Qualifications

• Minimum of 4 years of related work experience is required
• Medical Device experience is preferred
• A Bachelor’s Degree is required. A Bachelor’s Degree in Engineering is preferred.
• Proficient in Word, Excel, Power Point, Microsoft Project, and other specialty software as required
• Leadership experience is preferred
• Availability to travel up to 10% domestic is required
• Fully Bilingual (Spanish & English) required

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 .]