Document Control

Responsibilities

• Support 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.

Qualifications

• Experience 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.