Sterilization Quality Engineer III

SummaryThe Sterilization Quality Engineer Leads and maintains activities related to the control of the sterilization process as well control of semi-controlled rooms dedicated to the storage of special materials, defining strategies aligned with the philosophy and policies of the organization to achieve compliance with procedures, standards and specifications.Is responsible for the validation activities related to the sterilization cycles and product disposition post-sterilization of the EtO process. Ensures that the Sterilization process complies with its specifications and that the cycle meets applicable qualifications.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.Leads the development, modification, and maintenance of quality evaluation and protocols for processing materials into partially finished or finished products. Serve as a Validation Owner, ensuring that the validation processes are completed in accordance with the applicable ISO requirements (ISO 11135), including all ethylene oxide chambers revalidated and follow up with the customers when such revalidations must be performedReview and approval of EtO process batch record documentation. Coordinate sample manufacturing for validations and/or revalidations of ethylene oxide and residuals with Planning and Production. Audits quality systems for deficiency identification and correction. Lead EtO CAPA/NCs/Events/Customer Complaints root cause investigations related to sterilization, ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 13485), Jabil Problem Solving methods, and that documentation is complete and compliant with requirements. Ensure that CAPAs, NCMRs and customer complaints related to sterilization are handled in a timely manner. Participates in audits of sterilization centers. Participate in the internal audit program as an internal auditor and/or leader. Provide support to work cells, promote a culture of service. Pursue compliance of the process goals and objectives by determining individual and team results (i.e. operational metrics, results against project timelines, training documentation, attendance records, knowledge of operational roles and responsibilities, personal development goals). May supervise, train or provide mentoring to less experienced QA members. Perform team member evaluations professionally and on time. Recruit, interview and supervise Quality Engineers, Inspectors and Technicians. Foster good morale, a proactive and positive culture, and maximize the opportunity for personal growth within the QA Team Support all company safety and quality programs and initiatives. Responsible for the generation / updating / maintenance the Matrix for the direct reports. Comply and follow all procedures within the company security policy. Provide support to all Safety, Health and Environment (EHS) programs and initiatives to support our zero accidents culture. May perform other duties and responsibilities as assigned. Minimum RequirementsBachelor's degree required and five years related experience; or equivalent combination of education and experience., BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.