ITA - Scafati (SA) - Kerr Italia S.r.l.

R5027752

Italy

Quality and Regulatory Affairs

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.

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 premio, 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:

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 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.pdf

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Kerr

Operating Company:

Kerr

Location:

ITA - Scafati (SA) - Kerr Italia S.r.l.

Date Posted:

November 2 , 2026

Req Number:

R5027752

Benefits

Caring for our employees and their families

Health & Wellbeing

We 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 Benefits

We 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 Insurance

We 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 Off

We 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 Development

We 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 process

At 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 Review

After 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. Interviews

You’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 Decision

If 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. Onboarding

Once you join, we’ll support your transition with onboarding resources and guidance to help you get started and feel connected from day one.

📌 Quality Assurance Assistant (Scafati)
🏢 Kerr
📍 Scafati