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Ethicon Inc., a member of the Johnson & Johnson Family of Companies is recruiting for a Process Quality Lead. 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. Under the direction of the Business Unit Manager, 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 Ethicon’s QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process. As the Process Quality Lead, you will: 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 and process quality technicians 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. 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 several CAPA and should recommend CAPA’s based on negative trends. Handle and prepare data and present product escalation investigations (PRE’s), near misses and QRB. Lead in-process investigations and preliminary investigations of product complaints with a multifunction team to determine root causes and provide recommendations for corrections on preventive actions. Provide technical supervision to multilevel, cross functional teams. Provide supervision to technical professionals such as College Recruits, Coops or Supervisors that are assigned to work on projects related to process enhancement initiatives. Participate in site internal audits as a team or lead auditor to ensure compliance with all applicable quality system standards and directives in accordance with internal audit schedule. Assist preparations for and conduct of quality system external audits and inspections. Conduct audit finding investigations and reviews those finding with the respective area management or representative to assure a thorough understanding of the compliance issue and the requirements for effective, timely corrective actions. As required, cover manufacturing manager to provide the first level of supervision in a manufacturing unit. Supervise in accordance with established policies and methods to meet production commitments. Assigns duties and actively assists or provides direction to subordinates as required. Monitors work operations and employee performance. Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001)Qualifications A minimum of a Bachelor’s Degree in Engineering or Science is required. Master’s Degree, preferred. A minimum of six (6) years of relevant work experience is required. A minimum of five (5) years of experience in the QSR/ISO required - regulated medical device operation preferred. Experience in a quality role within the manufacturing industry preferred. Bilingual (Spanish & English) is a plus. Advanced computer skills (Microsoft Office) and use of software application(s) are required. Must have thorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques. Proficiency in the preparation of technical reports and presentations is required. Strong communication and interpersonal skills are required. Requires good negotiation skills. Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland. Leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills are required. May require working / visiting all three shifts of the operation and working irregular hours. Associate is required to wear gowning as per established Quality Procedures. The ability to regularly work with Hand Tools is required. This position may require up to 10% domestic and international travel.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 LocationUnited States-Texas-San Angelo-OrganizationEthicon Inc. (6045)Job FunctionQualityRequisition ID8362200210
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