Quality Assurance Assistant

Envista Holdings Corporation; Scafati; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

Kerr, part of Envista, is seeking a Quality Assurance professional in Italy to review device history records and drive investigations of nonconformances. You will provide oversight of calibration, validate documentation, and support regulatory reporting.

The role requires a bachelor’s degree in a relevant science/engineering field and 5+ years in regulated manufacturing environments, with fluency in Italian and English. Strong data analytics and cross-functional collaboration are essential.

Qualifikationen

• Five or more years of Quality Assurance, Quality Control, Manufacturing Quality, or laboratory quality experience in regulated environments.
• Experience independently managing nonconformances, investigations, CAPAs, complaints, document review, product release, or audit support.
• Working knowledge of ISO 13485 and EU Regulation 2017/745; familiarity with ISO 14971 and data integrity.

Aufgaben

• Review and disposition of Device History Records and batch records before product release.
• Lead or support investigations of nonconformances and CAPAs with root-cause analysis.
• Investigate customer complaints and analyze quality data for recurring failure modes.
• Support inspection activities and evaluation of materials, components, and finished products.
• Interpret lab results and oversee calibration and maintenance of inspection systems.
• Revise SOPs and support change-control activities and ECR/ECO processes.
• Participate in internal audits and regulatory inspections; prepare evidence and responses.
• Create quality dashboards and automated workflows using Power BI, Power Automate, Copilot, and Excel.
• Use AI-enabled tools for quality-record categorization and trend analysis with governance.

Kenntnisse

Analytical thinking

Attention to detail

Clear communication

Cross-functional collaboration

Problem solving

Italian language

English language

Ausbildung

Bachelor’s degree in Chemistry/ Chemical Engineering/ Biomedical Engineering/ Materials Science/ Biotechnology/ Industrial Engineering

Tools

Oracle ERP

Power BI

Power Automate

Copilot

Advanced Excel

Jobbeschreibung

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 elevate quality or compliance risks. 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.