Quality Engineer | ISO/IEC 17065 | Accreditation
2 giorni fa
Milan, Lombardy, Italia
ENAVE - Ente Navale Europeo
Tempo pieno
30.000 € - 50.000 €/anno
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Join ENAVE – Ente Navale Europeo and contribute to excellence in product certification and regulatory compliance.
ENAVE – Ente Navale Europeo is an independent Notified Body (No. 2406) operating in the recreational boating and industrial sectors. We support manufacturers in achieving product conformity and CE marking in accordance with applicable European legislation, combining technical expertise, professional integrity and intellectual independence.
As part of our continued growth and the expansion of our industrial certification activities, we are looking for a Quality Engineer to join our team in Milan.
Your Role
Reporting directly to the Quality Manager, you will play a key role in maintaining and continuously improving ENAVE’s Quality Management System (QMS), ensuring compliance with ISO/IEC 17065, accreditation requirements, Notified Body obligations and applicable EU legislation.
You will also contribute to the development of new certification activities, including applications for additional EU directives and regulations and extensions to ENAVE’s Notified Body scope.
Key Responsibilities
· Support the implementation, maintenance and continuous improvement of the Quality Management System in accordance with ISO/IEC 17065.
· Ensure compliance with applicable accreditation requirements, Notified Body obligations and relevant EU product legislation.
· Manage and maintain controlled quality documentation, including the quality manual, procedures, work instructions, forms and records.
· Coordinate internal audits, management reviews, nonconformities, corrective and preventive actions, complaints, appeals, impartiality and confidentiality processes.
· Prepare for and support external audits and assessments conducted by accreditation bodies, notifying authorities and EU peer evaluation teams.
· Assist in preparing applications for new directives and regulations, as well as extensions to ENAVE’s Notified Body scope.
· Conduct gap analyses and support implementation plans for new or revised regulatory and accreditation requirements.
· Monitor developments in European product conformity assessment legislation, particularly the Machinery Directive/Regulation, the Outdoor Noise Directive (OND), the Recreational Craft Directive (RCD) and CE marking requirements.
· Maintain training records, competence matrices, assessor qualifications and subcontractor approval documentation.
· Support risk management, data protection, impartiality and confidentiality activities.
· Prepare quality KPIs, performance reports and documentation for management review.
· Work closely with technical teams, certification personnel and management to ensure consistent application of quality procedures across certification activities. Requirements
· Bachelor’s degree in Engineering, Quality Management or a related technical field.
· At least 2 years of relevant professional experience in quality management, preferably within a Notified Body, certification body, accredited laboratory or conformity assessment organization.
· Strong working knowledge of ISO/IEC 17065.
· Familiarity with ISO/IEC 17021-1, ISO/IEC 17025 and/or ISO 9001.
· Understanding of the European conformity assessment framework, CE marking and applicable EU directives and regulations.
· Experience with audits, accreditation processes and regulatory documentation or applications.
· Excellent written and spoken English.
· Strong organizational, analytical and project management skills, with excellent attention to detail.
· Ability to work independently while collaborating effectively with multidisciplinary teams. Preferred Qualifications
· Lead Auditor certification.
· Experience interacting with accreditation bodies and/or notifying authorities.
· Experience preparing applications for new Notified Body designations or extensions of existing scopes.
· Knowledge of the Machinery Directive/Regulation, OND and/or RCD.
· Experience in EU product legislation, regulatory affairs and conformity assessment.
· Additional European languages. Position Details
• Job Title: Quality Engineer
• Company: ENAVE – Ente Navale Europeo
• Department: ENAVE Industrial
• Reports to: Quality Manager
•
Location:
Milan, Italy
• Employment Type: Full-time
• Compensation: €30,000–€50,000 gross annual salary (RAL), depending on experience and qualifications.
Key Responsibilities
· Support the implementation, maintenance and continuous improvement of the Quality Management System in accordance with ISO/IEC 17065.
· Ensure compliance with applicable accreditation requirements, Notified Body obligations and relevant EU product legislation.
· Manage and maintain controlled quality documentation, including the quality manual, procedures, work instructions, forms and records.
· Coordinate internal audits, management reviews, nonconformities, corrective and preventive actions, complaints, appeals, impartiality and confidentiality processes.
· Prepare for and support external audits and assessments conducted by accreditation bodies, notifying authorities and EU peer evaluation teams.
· Assist in preparing applications for new directives and regulations, as well as extensions to ENAVE’s Notified Body scope.
· Conduct gap analyses and support implementation plans for new or revised regulatory and accreditation requirements.
· Monitor developments in European product conformity assessment legislation, particularly the Machinery Directive/Regulation, the Outdoor Noise Directive (OND), the Recreational Craft Directive (RCD) and CE marking requirements.
· Maintain training records, competence matrices, assessor qualifications and subcontractor approval documentation.
· Support risk management, data protection, impartiality and confidentiality activities.
· Prepare quality KPIs, performance reports and documentation for management review.
· Work closely with technical teams, certification personnel and management to ensure consistent application of quality procedures across certification activities. Requirements
· Bachelor’s degree in Engineering, Quality Management or a related technical field.
· At least 2 years of relevant professional experience in quality management, preferably within a Notified Body, certification body, accredited laboratory or conformity assessment organization.
· Strong working knowledge of ISO/IEC 17065.
· Familiarity with ISO/IEC 17021-1, ISO/IEC 17025 and/or ISO 9001.
· Understanding of the European conformity assessment framework, CE marking and applicable EU directives and regulations.
· Experience with audits, accreditation processes and regulatory documentation or applications.
· Excellent written and spoken English.
· Strong organizational, analytical and project management skills, with excellent attention to detail.
· Ability to work independently while collaborating effectively with multidisciplinary teams. Preferred Qualifications
· Lead Auditor certification.
· Experience interacting with accreditation bodies and/or notifying authorities.
· Experience preparing applications for new Notified Body designations or extensions of existing scopes.
· Knowledge of the Machinery Directive/Regulation, OND and/or RCD.
· Experience in EU product legislation, regulatory affairs and conformity assessment.
· Additional European languages. Position Details
• Job Title: Quality Engineer
• Company: ENAVE – Ente Navale Europeo
• Department: ENAVE Industrial
• Reports to: Quality Manager
•
Location:
Milan, Italy
• Employment Type: Full-time
• Compensation: €30,000–€50,000 gross annual salary (RAL), depending on experience and qualifications.