Senior Quality Engineer - Sterilization Tech

- Ensure adherence to all regulations, standards, procedures, and work instructions outlined in the Quality System Manual. - Review, investigate, and manage the Complaint system, including documentation and closure tasks. - Initiate, investigate, and document CAPAs, guaranteeing timely resolution and appropriate risk management actions. - Develop or revise procedures, work instructions, forms, and labels to support quality, manufacturing, and engineering processes. - Conduct internal, supplier, and design history file audits. - Assist with inspections and audits conducted by FDA, Notified Bodies, OSHA, and others. - Lead or assist with customer audits as necessary. - Review and authorize sterile product release, ensuring compliance with sterilization specifications and documentation requirements. - Analyze sterilization batch records (EtO and/or Gamma) for completeness and conformity. - Support sterilization validation and re-qualification efforts, including protocol review, data analysis, and reporting. - Collaborate with sterilization vendors to address nonconformances, deviations, environmental excursions, and cycle performance issues. - Maintain sterilization-related technical files, such as biological indicators, dose audits, and residual testing (for EtO) and dose mapping studies (for Gamma). - Ensure compliance with sterilization standards (e.g., ISO 11135 for EtO, ISO 11137 for Gamma). - Assist with risk assessments related to sterilization processes, bioburden changes, material compatibility, and packaging integrity. - Support supplier performance management and sourcing projects. - Maintain technical documentation including clinical evaluation reports, essential requirements, usability engineering reports, risk management files, and verification/validation reports. - Assist with document changes, training, incoming inspection, in-process inspection, label inspection, and nonconforming material activities.