Category: Administrative / Clerical / Assistant
Industry: Medical Equipment Manufacturing
Job type: Full-time
Job contentThe Kerr Dental portfolio of brands and product solutions spans restoratives, endodontics, and rotary instruments, with a common purpose of enabling healthy, beautiful smileswhile providing an exceptional customer experience globally. Kerr’s 130+ year history of innovation began in 1891 in Detroit, Michigan and has since expanded on a global scale to ensure dental professionals receive the consumable products they trust most. Kerr’s market-leading brands include OptiBond, SonicFill, Harmonize, MaxCem Elite, and many more. Learn more at www.kerrdental.com
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.
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.
Degree Qualification In Scientific Subject Preferred.
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 .
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista’s internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
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