Provide quality assurance and technical sterilization support to the terminal sterilization of medical devices and other healthcare products. The position will support the Medline Product Divisions and external customers in order to maintain compliance to regulations and industry standards including 21 CFR Part 820, ISO11135 and ISO13485.
* Host internal and external audits including customers and regulatory bodies. Represent the facility on matters pertinent to the Quality Management System as established through regulations, industry standards and procedures. Assist audit team in vendor audits as needed for technical support.
* Work with plant employees and management to identify root cause and implement corrective actions as required due to process deviations, complaints, and audits. Develop responses and interact with customers or regulatory agencies related to audit findings or requests.
* Review sterilization records and all related documentation for completeness, accuracy, and to ensure they meet validated parameters prior to releasing product for distribution. Maintain sterilization files and document libraries.
* Facilitate the maintenance of local training documentation for plant employees. Develop training materials and train employees in response to procedural change, policy changes and improvement activities.
* Create and update NPS procedures, Quality System Forms, Specifications and other controlled documents including sterilization process parameters as needed for improvements to the process and to maintain compliance to industry and regulatory standards.
* Prepare sterilization validation protocols and final reports for NPS customers. Interact with individuals from different disciplines (Production, Maintenance, and Customers) to plan, execute and complete multiple simultaneous EO validation activities or customer special requests with time sensitive schedules. Coordinate and assist in validation product load set up and sample/sensor retrievals.
Bachelor’s degree with a scientific or engineering background
US Visa required
3+ Years working in FDA/ISO 13485 regulated environment (Desirable)
3+ Years working in Medical Device manufacturing (Desirable)
Knowledge in ISO standar 11135 (Desirable)
Able to manage multiple projects
|Área||Control de Calidad|