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Process Quality Leader

Process Quality Leader
Empresa:

Johnson&Johnson


Detalles de la oferta

Ethicon, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Process Quality Leader, located in San Lorenzo, Puerto Rico.

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.

The selected candidate will:
• Dedicate to develop, manufacture, and market quality products and to promote a quality.
• Review and analyze quality trends with the manufacturing team. Considering the quality trends provides 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 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.
• Lead investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, facilities the implementation process.
• Analyze of data and based on the trends recommends actions for process, equipment and system.
• 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. (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.
• Handle, prepare data and present product escalation investigations (PRE’s), near misses and QRB.
• Lead in-process investigations with a multifunction team to determine root causes and provides recommendations for corrections on preventive actions.
• Handle preliminary investigations of product complaints, analysis, trends and recommendations or leads corrective/preventive actions.
• Provide technical supervision to multilevel, cross functional teams. Provides supervision to technical professionals such as College Recruits, Coops or Supervisors that are assigned to work on projects related to process enhancement initiatives.
• Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Qualifications
• A minimum of bachelor’s degree is required: Engineering or Science is preferred.
• Master’s degree, Six Sigma, Lean, PMP, CQE, CQA, CQMOE Certifications are preferred.
• A minimum of five (5) years of experience in Medical Devices, Pharmaceuticals or Consumer is required, with two (2) years of hands-on experience working with change controls, implementations, investigations, CAPA and non-conformance reporting.
• Experience working in a quality role within the manufacturing industry is highly desired.
• Thorough knowledge of Quality System Regulation (QSR), Good Manufacturing Practices (GMP), International Organization for Standardization (ISO), applied statistics and failure mode analysis techniques is required.
• Exposure to quality systems and experience supporting FDA audits is preferred.
• Proficiency with Microsoft Office applications (Word, Excel, Power Point and Outlook) is required.
• Experience with Minitab is preferred.
• Proficiency in the preparation of technical reports, documentation and presentations is required.
• Bilingual proficiency in English and Spanish (oral and written) is required.
• This position requires up to ten percent (10%) of travel and may require working/visiting all three shifts of the operation and working irregular hours.

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.
Primary Location
United States-Puerto Rico-San Lorenzo- Organization
Ethicon Endo Surgery, LLC (7597)
Job Function
Engineering
Requisition ID
1122200824


Fuente: Bebee2

Requisitos

Process Quality Leader
Empresa:

Johnson&Johnson


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