Quality Assurance Assistant

Description

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:

Kerr

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:
• Kerr