Detalle de la Oferta

Descripción de la Oferta

SUMMARY

The 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 performed
- Review 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 REQUIREMENTS
Bachelor's degree required and five years related experience; or equivalent combination of education and experience.