Quality Assurance Assistant

Envista; Campania; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

Kerr Italia S.r.l. in Scafati (SA) seeks a Quality Assurance Assistant to review documents, lead investigations, and manage CAPAs for medical devices in a regulated setting. The role supports inspections, data analysis, and change control, collaborating with cross-functional teams.

Requirements include a Bachelor’s degree in a scientific/technical field and 5+ years in QA roles, plus fluency in Italian and English. On-site position with growth in automation and AI-assisted processes.

Competenze

• Bachelor’s degree in a scientific/technical discipline is required.
• Five+ years of QA, QC, or related industry experience in regulated environments.
• Experience managing nonconformances, investigations, CAPAs, and audits.

Mansioni

• Review manufacturing and quality documentation and disposition device history records and batch records.
• Lead or support investigations of nonconformances and CAPAs through closure.
• Investigate customer complaints and assess quality data for trends.
• Support inspections, calibration, maintenance, and lab or inspection systems.
• Prepare quality metrics, risk reports, and escalation items for stakeholders.
• Create dashboards and automated workflows using Power BI, Excel, or AI-enabled tools.

Conoscenze

Quality Assurance

Investigations & CAPA

ISO 13485

Data analysis

Italian & English

Formazione

Bachelor’s degree in Chemistry/Engineering/Science

Strumenti

Oracle/ERP systems

Quality Management Systems

Power BI / Excel dashboards

AI-enabled tools

Descrizione del lavoro

Quality Assurance Assistant# Envista Careers## Quality Assurance AssistantApply: ITA - Scafati (SA) - Kerr Italia S.r.l.: Full time: Posted Today: R5027752**Job Description:**# **Key Responsibilities*** Review manufacturing and quality documentation and perform final review and disposition of Device History Records, batch records, or lot history records before product release.* Lead or support investigations of internal, supplier, and product nonconformances; apply structured root-cause analysis; and own assigned CAPAs through effectiveness verification and closure.* Investigate customer complaints, evaluate returns and quality data, identify recurring failure modes, and support regulatory-reportability assessments when applicable.* Support incoming, in-process, and final inspection, including visual, dimensional, functional, and analytical evaluation of materials, components, and finished products.* Interpret inspection and laboratory results and support oversight of calibration, preventive maintenance, out-of-tolerance assessments, and laboratory or inspection systems.* Review and revise SOPs, work instructions, test methods, forms, and calibration procedures; support ECR/ECO and change-control activities.* Participate in internal audits and inspections by notified bodies, regulatory authorities, customers, or corporate auditors, including preparation, evidence collection, responses, and follow-up.* Create quality dashboards and automated workflows using Power BI, Power Automate, Copilot, advanced Excel, or comparable platforms.* Use 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.* Prepare and communicate quality metrics, trends, risks, and escalation items to cross-functional stakeholders and leadership.**Job Requirements:**# **Required Qualifications*** Bachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, Biotechnology, Industrial Engineering, or a related scientific or technical discipline.* Five 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.* Demonstrated experience independently managing nonconformances, investigations, CAPAs, complaints, document review, product release, or audit support.* Working knowledge of ISO 13485 and Regulation (EU) 2017/745; familiarity with ISO 14971, Good Documentation Practices, data integrity, and structured root-cause analysis.* Experience with ERP or electronic quality-management systems; Oracle experience is an advantage.* Experience with workflow automation, dashboards, advanced data analysis, or approved AI-enabled business tools.* Fluent Italian and professional working proficiency in English.# **Preferred Qualifications**Experience 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.# **What You Bring**Strong technical judgment, attention to detail, analytical problem solving, clear communication, digital curiosity, effective cross-functional collaboration, and the confidence to raise and escalate quality or compliance risks. You can distinguish appropriate automation opportunities from decisions requiring qualified human judgment.****Operating Company:****KerrEnvista 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.