Quality Assurance Assistant

Envista; Scafati; On-site; EUR 60,000 - 90,000; Full time

Job summary

Envista in Scafati, Campania, seeks a Quality Assurance professional to review manufacturing and quality records, manage nonconformances, CAPAs, and support regulatory reporting in a regulated medical devices environment. ISO 13485 and EU MDR knowledge preferred.

You will build quality dashboards, automate workflows with Power BI and Excel, apply AI-enabled tools for data-driven investigations, and ensure data integrity, traceability, and cross-functional collaboration across the organization.

Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, Biotechnology, Industrial Engineering, or a related discipline.
• Five or more years of Quality Assurance/Quality Control in regulated manufacturing.
• Experience managing nonconformances, investigations, CAPAs, and audits.
• Experience with ISO 13485 and EU 2017/745; familiarity with ISO 14971, Good Documentation Practices.
• Experience with ERP or electronic quality-management systems; Oracle is a plus.
• Fluent Italian and professional English.

Responsibilities

• Review manufacturing and quality documentation and perform final disposition of records before product release.
• Lead or support investigations of nonconformances; apply root-cause analysis; own CAPAs through closure.
• Investigate customer complaints, evaluate returns and quality data, identify recurring failure modes.
• Support inspections, calibration, maintenance, and laboratory evaluations.
• Review and revise SOPs, work instructions, and change-control activities.
• Participate in internal audits and regulatory inspections; preparation and follow-up.

Skills

Quality Assurance

Root cause analysis

Investigations

Documentation review

Data analysis

Audits

Italian language

English proficiency

Education

Bachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, Biotechnology, Industrial Engineering, or related field

Tools

ERP systems

Oracle

Quality Management Systems

Job description

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:

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 escalation items to cross-functional stakeholders and leadership. You can distinguish appropriate automation opportunities from decisions requiring qualified human judgment.

Operating Company:

Kerr 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. 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 DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry.

For more information:

For more information, please visit www.envistaco.com.