Supplier Quality Engineer

Enovis; San Daniele del Friuli; On-site; EUR 45,000 - 65,000; Full time

Job summary

Enovis is seeking a Supplier Quality Engineer to join its global medical technology team in Italy. You will oversee supplier qualification, audits, and quality improvement programs across international suppliers, collaborating with R&D, Purchasing, and regulatory functions.

The role requires a mechanical/biomedical engineering degree, strong Excel skills, English at least B2, basic German, and willingness to travel within Italy and abroad. Candidates with Lead Auditor certification are a plus.

Qualifications

• Bachelor’s or Master’s degree in Engineering (Mechanical, Management, Biomedical or Bioengineering).
• Experience in supplier quality assurance in modern manufacturing.
• Excellent knowledge of Microsoft Office, particularly Excel.
• Ability to work with precision and method, and multitask.
• Team-oriented with effective collaboration skills.
• Fluent written and spoken English (at least B2).
• Basic German (written and spoken).
• Willingness to travel short-term within Italy and abroad.
• Lead Auditor qualification (AICQ-CEPAS, AICQ-SICEV) is an advantage.

Responsibilities

• Create and maintain Quality Management System procedures and work instructions.
• Manage quality records required by QMS procedures and work instructions.
• Support analysis of supplier quality KPIs and root-cause investigations.
• Manage qualification and surveillance of suppliers, including audits.
• Support suppliers in improvement plans after audits and nonconformities.
• Evaluate suppliers' process validation strategies with R&D and technical departments.
• Communicate with suppliers on product and process quality topics.
• Collaborate with R&D to identify improvements to technical documentation.
• Collaborate with Purchasing to identify alternative/new sources.
• Support Post Marketing Surveillance in case of outsourced production complaints.
• Support Incoming Inspection in evaluating product non-conformities.
• Support Regulatory with supplier processes for registrations.
• Assist during inspections of Certification Bodies and authorities.
• Recommend corrective measures to minimize nonconformities.
• Manage initial sampling with suppliers.

Skills

Excel

Teamwork

Precision & method

English (B2)

German (basic)

Travel willingness

Education

Engineering degree (Mechanical/Management/Biomedical/Bioengineering)

Tools

MS Office

Job description

ENOVIS™

Enovis Corporation (NYSE: ENOV) è un'azienda in crescita nel settore delle tecnologie mediche orientata all'innovazione e dedicata allo sviluppo di soluzioni clinicamente differenziate che migliorano in modo misurabile i risultati dei pazienti e trasformano i flussi di lavoro. Grazie a una cultura del miglioramento continuo, al talento globale e all'innovazione, l'ampia gamma di prodotti, servizi e tecnologie integrate dell'azienda alimenta stili di vita attivi in ortopedia e non solo. Per ulteriori informazioni su Enovis, visitare il sito www.enovis.com.

Chi siamo

Enovis Corporation (NYSE: ENOV) è un'azienda in crescita nel settore delle tecnologie mediche orientata all'innovazione e dedicata allo sviluppo di soluzioni clinicamente differenziate che migliorano in modo misurabile i risultati dei pazienti e trasformano i flussi di lavoro. Grazie a una cultura del miglioramento continuo, al talento globale e all'innovazione, l'ampia gamma di prodotti, servizi e tecnologie integrate dell'azienda alimenta stili di vita attivi in ortopedia e non solo. Per ulteriori informazioni su Enovis, visitare il sito www.enovis.com.

Who We Are

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.

Di cosa ti occuperai | What You'll Do

We are looking for a Supplier Quality Engineer with experience gained within modernly organized manufacturing companies in the selection, qualification, monitoring and revaluation processes of new and consolidated Suppliers. The position requires you to work in an international context, actively collaborating with colleagues present in other company offices.

Main Responsibilities

• Create and maintain pertinent Quality Management System procedures and work instructions (e.g.: SOP, WIN, FRM. General Quality Conditions, Procurement Specifications).
• Manage and collect quality records required by pertinent Quality Management System procedures and work instructions.
• Support the analysis of supplier quality KPIs and nonconformities trends and perform root cause investigations.
• Manage the qualification and surveillance of Suppliers (including the execution of audits when qualified as auditor).
• Support Suppliers in the definition and implementation of improvement/correction plans following Supplier audits, product nonconformities, SCARs).
• Evaluate Suppliers’ process validation strategies and records (in collaboration with the Process Validation, R&D and Technical Departments, as applicable).
• Communicate with Suppliers about product and process quality topics.
• Cooperate with R&D department to identify necessary improvements or modifications to technical documentation (e.g.: product drawings, technical specifications).
• Cooperate with Purchasing Department for the identification and implementation of alternative and new sources.
• Support Post Marketing Surveillance Department in case of complaints correlated to outsourced productions.
• Support Incoming Inspection Department in the evaluation of product non-conformities.
• Support Regulatory Department with information on suppliers’ processes to register new products or to renew existing product registrations.
• Support the Manager during inspections of Certification/Notified Bodies, Competent Authorities and Agencies.
• Recommend to internal departments and suppliers suitable corrective measures be implemented to minimize nonconformities.
• Manage with suppliers the initial sampling process.

Skills Required

• A bachelor’s or master’s degree in Engineering (preferably Mechanical, Management, Biomedical or Bioengineering).
• Previous experience in supplier quality assurance, gained in modern manufacturing companies.
• Excellent knowledge of Microsoft Office, particularly Excel.
• Ability to work with precision and method (including on multiple tasks simultaneously).
• Ability to work effectively in a team.
• Excellent knowledge of written and spoken English (at least B2 level).
• Basic knowledge of written and spoken German.
• Willingness to undertake short-term travel within Italy and abroad.
• Lead Auditor qualification (accredited by AICQ-CEPAS, AICQ-SICEV) is considered an advantage

Dichiarazione di pari opportunità

Enovis si impegna a garantire pari opportunità di lavoro a tutti. Le decisioni relative all'assunzione si basano esclusivamente sul merito, sulle qualifiche e sulle esigenze aziendali. Applichiamo una politica di parità di trattamento per tutti i dipendenti e i candidati, senza discriminazioni basate su razza, colore della pelle, religione, nazionalità, sesso, orientamento sessuale, identità di genere, età, status di veterano, disabilità o qualsiasi altra caratteristica non correlata alle qualifiche o alle prestazioni lavorative di una persona. Questo impegno si estende a tutti gli aspetti dell'occupazione, tra cui reclutamento, assunzione, assegnazione dei compiti, retribuzione, formazione, promozione, retrocessione, trasferimenti, licenziamenti, provvedimenti disciplinari e cessazione del rapporto di lavoro, nonché a tutti gli altri termini e condizioni di impiego.

Equal Employment Opportunity

At Enovis, we are committed to providing equal employment opportunities to all individuals. Employment decisions are based solely on merit, qualifications, and the needs of the business. We uphold a policy of equal treatment for all employees and applicants, without discrimination based on race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, or any other characteristics unrelated to a person’s qualifications or job performance. This commitment extends to all aspects of employment, including recruitment, hiring, job assignments, compensation, training, promotion, demotion, transfers, layoffs, discipline, and separation, as well as all other terms and conditions of employment.