Qs Specialist

Operating Company: Kerr
Location: Salerno,Campania,IT
Date Posted: August 31, 2023
Req Number: R5017157

Provides analysis, counsel, quality assurance, and regulatory and compliance technical training services to the organization. Individuals within this job family analyze quality/regulatory aspects of operations activity, and recommend actions that maximize efficiencies, ensure compliance quality, and provide the highest level of customer service.

This position supports activities related to ISO accreditation of the organization, internal audits, and external audits to ensure QA and regulatory compliance to all applicable normative and ISO requirements, assistance/coordinate 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.

Contribute to the Quality Assurance Management System on site to ensure continuous improvement of quality performance, achievement of the plant's quality objectives, quality product.

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. Handle, maintain electronic records and documentation according to applicable normative (MDR etc.) and ISO standard.

Handling of Documentation according to requirement of ISO, 21CFR Part 820 and all applicable normative.

Receive, process, handle and implement requests of change control according to QMS and maintain the requests via tracking log.

Update documentation.

Create new templates, elaborate SOPs and work instructions. Support to analyze the needs of updating Quality procedures to guarantee the compliance according to the regulations.

Support the quality compliance in developing, planning, maintaining the internal audit program, and monitor the status of non-compliances of audits.

Perform training on records management procedures, which include documentation, retention and QMS. Elaborate, maintain training records, handle electronic training system and maintain/update training matrix with the collaboration with other responsibles. Can assist audit. Lead the back room during audits.

Cooperate with other sites to harmonize QA/Regulatory activities and processes to optimize QMS.

**Job Requirements**:
Experience in a medical devices or regulated business. Experience working to MDR, ISO 13485 and FDA compliant systems.

Experience in audits preferred.

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 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 the different functions.

ASQ Certificate would be a plus.

**Operating Company**:
Kerr