Ethicon LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a 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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
As the Process Quality Leader, you will:
? 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 the company's requirements for the entire business unit manufacturing process.
? Review and analyze quality trends with the manufacturing team, considering that quality trends provide direction in terms of setting work priorities for process enhancement.
? Provide guidance to Manufacturing Supervisors to ensure that effective in-depth investigations are performed. Provide leadership and guidance to cross-functional, multilevel technical teams to assure non-conformance causes are identified / understood and that sound Corrective and Preventive Actions (CAPA) are implemented. Evaluate the implemented CAPA against trends to assess effectiveness.
? Lead investigations and facilitate the implementation process, in alignment with the Process Engineer and the Manufacturing Manager.
? Analyze data and based on the trends recommend actions for process, equipment and system improvement.
? Write procedures, protocols and any other documentation needed for the enhancement of processes and systems.
? Provide training and education to the manufacturing team on tools for process evaluation and enhancement. (e.g. Analytical trouble shooting, statistical concept application and Quality System Regulation / ISO requirements).
? May lead several CAPA and should recommend CAPA's based on trends as wells as prepare data to present product escalation investigations (PRE's) and near misses.
? Lead in-process investigations with a multifunctional team to determine root causes and manage preliminary investigations of product complaints.
? Provide technical supervision to multilevel, cross functional teams including College Recruits, Coops or Supervisors that are assigned to work on projects related to process enhancement initiatives.
? A minimum of bachelor's degree in Engineering or Science is required. Master's degree is preferred.
? A minimum of five (5) years of experience in a regulated manufacturing environment is required.
? Hands-on experience working with change controls, implementations, investigations, CAPA and non-conformance reporting.
? Experience working in Medical Devices industry is highly preferred.
? Experience working in a quality role within the manufacturing industry is preferred.
? Must have thorough knowledge of Quality System Regulation (QSR), Good Manufacturing Practices (GMP), International Organization for Standardization (ISO), applied statistics and failure mode analysis techniques.
? Exposure to quality systems and experience supporting FDA audits is preferred.
? Must be proficient in Microsoft Office applications (Word, Excel, Power Point and Outlook).
? Must be proficient in the preparation of technical reports, documentation and presentations.
? The position requires problem solving, leadership, influential and negotiation skills as well as initiative, creativity, assertiveness, attention to detail, strong negotiation, communication and interpersonal skills.
? Must be Bilingual (English and Spanish, oral and written).
? This position requires up to ten percent (10%) of travel and may require working / visiting all three shifts of the operation and working irregular
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.
United States-Puerto Rico-San Lorenzo-
Ethicon Endo Surgery, LLC (7597)
815####### Associated topics: general surgery, laparoscopic, robotics, surg, surgeon, surgery, surgery physician
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.