ResponsibilitiesSupport activities related to ISO accreditation of the organization, internal audits, external audits, assistance for sending to accreditation bodies and resolution of non-conformances to ensure compliance with laws, regulations, rules and codes at federal, state and local levels.Handle documentation according to ISO 13485, 21 CFR Part 820 and all applicable regulatory norms.Support the compliance of Kerr Italia with all applicable norms (MDR, FDA, etc.).Support the QSM in data analysis to improve quality performance and achieve the plant's quality objectives.Assist the maintenance of quality systems and facilitate continuous quality improvements.Support the QSM in planning and maintaining the internal audit program and monitor the status of non-conformances from audits.Support the analysis of needs for updating Quality System procedures to guarantee compliance with regulations.Scan, organize and maintain documents, and archive inactive records in accordance with the records retention schedule; oversee retrieval of documents.Receive and process requests for information from employees and maintain the requests via a tracking log.Update documentation and create new templates.Support, develop and maintain document approvals and related items.Perform trainings on QMS and related procedures. Support and assist audits.Perform internal audits according to ISO 13485.Assume and perform other tasks as assigned.QualificationsExperience in a regulated business. Experience working with ISO 13485 and FDA-compliant systems.Language skills: English and Italian.Demonstrated communication skills, both written and verbal.Demonstrated organizational and prioritization skills.Proficient in Microsoft Word, Excel, and PowerPoint.Ability to read and understand quality documentation, production records, and work procedures related to compliance with applicable regulations.Ability to develop and analyze quality data.Ability to interact and communicate effectively with different functions.ASQ Certificate would be a plus. Experience with Toyota Production System principles is a plus. Knowledge in validation processes is desired.
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