Document Control

**This position supports activities related to ISO accreditation of the organization, internal audits, external audits, assistance for sending to accreditation bodies and resolution of non-compliance to ensure compliance with laws, regulations, rules and federal, state and federal codes, local laws.**

**Handling of Documentation according to requirement of ISO 13485, 21CFR Part 820 and all applicable regulatory normatives.**

**Support the compliance of Kerr Italia to all applicable normatives (MDR, FDA etc.).**

**Support the QSM in data analysis for improving quality performance, the achievement of the plant's quality objectives.**

**Assist the maintenance of quality systems and facilitates continuous quality improvements**

**Support the QSM in planning and maintaining the internal audit program and monitor the status of non-compliances of audits.**

**Support to analyze the needs of updating Quality System procedures to guarantee the compliance**

**according to the regulations.**

**Scan, organize and maintain documents, and they archive inactive records in accordance with the records retention schedule. A large part of the job is to control the retrieval of documents.**

**Receive and process requests for information from employees and maintain the requests via tracking log.**

**Update documentation.**

**Create new templates.**

**Support and develop and maintain documents 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.**

**Job Requirements**:
**Experience in a regulated business. Experience working to ISO 13485 and FDA compliant systems.**

**Language skills: English and Italian.**

**Demonstrated communication skills both written and verbal**

**Demonstrated organizational, prioritization skills**

**Demonstrated Microsoft Word, Excel, PowerPoint, experience**

**Ability to read and understand quality documentations, production records, work procedures related to compliance with applicable regulations**

**Ability to develop and analyze quality data**

**Ability to interact and communicate effectively with the different functions.**

**ASQ Certificate would be a plus. Experience with toyota production system principles is considered a plus. Knowledge in validation processes is a wish**.

**Operating Company**:
Kerr

**About Envista**:
Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists’ clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including KaVo, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.