Quality Assurance Specialist

Envista Holdings; Scafati; Presencial; EUR 60.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare benefits

Retirement plan

Life insurance

Paid time off

Career development

Descripción de la vacante

Kerr Italia S.r.l. cerca un professionista Quality & Regulatory Affairs per garantire conformità, gestione CAPA e supporto alle ispezioni.

La figura analizzerà documenti, gestirà non conformità, auditing e dashboards di qualità con Power BI, integrando strumenti ERP/Oracle e pratiche GMP/ISO 13485.

Formación

• Laurea in chimica o disciplina affine.
• Almeno 5 anni di esperienza in QA/QC in contesti regolamentati (dispositivi medici o pharma).
• Conoscenza di ISO 13485 e EU MDR; gestione CAPA e audit.
• Competenza su ERP/Oracle e strumenti di analisi dati.

Responsabilidades

• Revisionare documenti di produzione e qualità e rilasciare lotti.
• Indagare su non conformità e supportare CAPA fino a verifica di efficacia.
• Gestire audit interni, supporto ispezioni e preparazione evidenze.
• Creare dashboard di qualità e automatizzare flussi con strumenti dati.

Conocimientos

ISO 13485

EU MDR 2017/745

Data integrity

Root cause analysis

CAPA management

ERP/Oracle

Fluent Italian

English proficiency

Educación

Bachelor’s degree in Chemistry or related field

Herramientas

Power BI

Power Automate

Copilot

Advanced Excel

Oracle ERP

Descripción del empleo

ITA - Scafati (SA) - Kerr Italia S.r.l.R5027752ItalyQuality and Regulatory AffairsJob descriptionKey ResponsibilitiesReview 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 requirementsRequired QualificationsBachelor’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 QualificationsExperience 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 BringStrong 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.Target Market Salary Range:Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan.-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.Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdfRead moreKerrOperating Company:KerrLocation:ITA - Scafati (SA) - Kerr Italia S.r.l.Date Posted:November 2 , 2026Req Number:R5027752BenefitsCaring for our employees and their familiesHealth & WellbeingWe offer comprehensive programs designed to support the health and wellbeing of our employees and their families. From medical coverage to wellness resources, we prioritize helping our people thrive both physically and mentally.Retirement & Financial BenefitsWe are committed to supporting our employees’ financial wellbeing—today and in the future. Our competitive compensation and retirement or savings programs are designed to help employees build financial confidence at every stage of their careers.Life & Disability InsuranceWe provide benefits that help protect employees and their loved ones when it matters most. Depending on location, our life and disability programs offer valuable financial security and added peace of mind during unexpected life events.Paid Time OffWe know that time away from work is essential for rest, balance, and personal priorities. Our paid time off, holidays, and leave programs are designed to give employees the flexibility to recharge and take care of what matters most.Learning & Career DevelopmentWe believe in investing in our people. Through learning opportunities, development programs, and career growth pathways, we empower employees to build meaningful careers and continue growing with us.Our hiring processAt Envista, we’re committed to helping you feel confident and prepared every step of the way. Our interview guide will walk you through what to expect, how to showcase your strengths, and how you can make an impact by helping us champion dental professionals and improve lives.1. Application ReviewAfter you apply, our team will review your experience and qualifications. If your background aligns with the role, a recruiter will reach out to discuss the opportunity and next steps.2. InterviewsYou’ll meet with members of the hiring team to learn more about the role and share your experience. Depending on the position, this may include multiple conversations focused on your skills, experience, and how you can make an impact.3. Offer DecisionIf selected, you’ll receive an offer outlining compensation, benefits, and other details. Our team will guide you through the process and answer any questions to help you make an informed decision.4. OnboardingOnce you join, we’ll support your transition with onboarding resources and guidance to help you get started and feel connected from day one.