h3Key Responsibilities /h3 /brul /brliReview manufacturing and quality documentation and perform final review and disposition of Device History Records, batch records, or lot history records before product release. /li /brliLead or support investigations of internal, supplier, and product nonconformances; apply structured root-cause analysis; and own assigned CAPAs through effectiveness verification and closure. /li /brliInvestigate customer complaints, evaluate returns and quality data, identify recurring failure modes, and support regulatory-reportability assessments when applicable. /li /brliSupport incoming, in-process, and final inspection, including visual, dimensional, functional, and analytical evaluation of materials, components, and finished products. /li /brliInterpret inspection and laboratory results and support oversight of calibration, preventive maintenance, out-of-tolerance assessments, and laboratory or inspection systems. /li /brliReview and revise SOPs, work instructions, test methods, forms, and calibration procedures; support ECR/ECO and change-control activities. /li /brliParticipate in internal audits and inspections by notified bodies, regulatory authorities, customers, or corporate auditors, including preparation, evidence collection, responses, and follow-up. /li /brliCreate quality dashboards and automated workflows using Power BI, Power Automate, Copilot, advanced Excel, or comparable platforms. /li /brliUse approved AI-enabled tools for quality-record categorization, trend identification, document comparison, and investigation summaries, with appropriate verification, human oversight, data integrity, confidentiality, and validation controls. /li /brliPrepare and communicate quality metrics, trends, risks, and escalation items to cross-functional stakeholders and leadership.



/li /br /ul /brh3Job Requirements /h3 /brh3Required Qualifications /h3 /brul /brliBachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, Biotechnology, Industrial Engineering, or a related scientific or technical discipline. /li /brliFive or more years of Quality Assurance, Quality Control, Manufacturing Quality, or laboratory quality experience in medical devices, dental devices, pharmaceuticals, or a comparably regulated manufacturing environment. /li /brliDemonstrated experience independently managing nonconformances, investigations, CAPAs, complaints, document review, product release, or audit support. /li /brliWorking knowledge of ISO 13485 and Regulation (EU) 2017/745; familiarity with ISO 14971, Good Documentation Practices, data integrity, and structured root-cause analysis. /li /brliExperience with ERP or electronic quality-management systems; Oracle experience is an advantage. /li /brliExperience with workflow automation, dashboards, advanced data analysis, or approved AI-enabled business tools. /li /brliFluent Italian and professional working proficiency in English. /li /br /ul /brh3Preferred Qualifications /h3 /brpExperience with dental materials, chemical-based medical devices, consumables, analytical laboratory equipment, validated computerized systems, statistical trending, FDA medical-device quality requirements, or a global matrixed organization. Quality Engineer, lead auditor, or Six Sigma certification is an advantage. /p /brh3What You Bring /h3 /brpStrong technical judgment, attention to detail, analytical problem solving, clear communication, digital curiosity, effective cross-functional collaboration, and the confidence to raise and elevate quality or compliance risks. You can distinguish appropriate automation opportunities from decisions requiring qualified human judgment. /p /brpOperating company: Kerr /p #J-18808-Ljbffr

📌 Quality Assurance Assistant (Scafati)
🏢 Kerr Dental
📍 Scafati