Quality Manager - medical devices

Michael Page International Italia S.r.l.; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

Un'importante azienda del settore dispositivi medici cerca un Quality Manager a Milano. Il candidato ideale avrà un'esperienza consolidata nella gestione della qualità, garantirà la conformità alle normative e guiderà le iniziative di miglioramento continuo. Il ruolo richiede una forte leadership e capacità di problem-solving in un ambiente di produzione regolamentato.

Competenze

• Minimum 8 years of experience in quality management within the medical device industry.
• Proven experience in managing cross-functional teams in a regulated manufacturing environment.
• In-depth knowledge of EU MDR 2017/745, ISO 13485, FDA 21 CFR Part 820.

Mansioni

• Ensure product and process quality on the production floor, including in-process controls and final inspections.
• Lead and support investigations for nonconformances and implement effective corrective actions.
• Monitor and report quality performance indicators, identify trends, and lead improvement initiatives.

Conoscenze

Problem-solving

Leadership

Communication

Organizational

Formazione

Bachelor's degree in engineering or life sciences

Strumenti

8D

Fishbone

FMEA

Descrizione del lavoro

• Milano
• Quality Manager

Azienda

We are seeking a Quality Manager to lead and oversee all aspects of quality assurance across production operations and the Quality Management System (QMS). This role ensures consistent product quality, regulatory compliance, and continuous improvement in line with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.

Offerta

• Ensure product and process quality on the production floor, including in-process controls, final inspections, product release, and handling of manufacturing deviations.
• Lead and support investigations for nonconformances, complaints, and deviations; drive root cause analysis and implement effective corrective and preventive actions (CAPAs).
• Coordinate with the Quality System Manager to ensure QMS elements (e.g., documentation, audits, training, change control, risk management) are properly implemented and maintained.
• Support validation activities related to manufacturing processes, equipment, and test methods to ensure compliance with GMP and regulatory requirements.
• Act as the quality interface between production, engineering, regulatory, and supply chain teams to resolve quality issues, support design transfer, and ensure compliant operations.
• Monitor and report quality performance indicators (e.g., defect rates, yield, complaints), identify trends, and lead improvement initiatives.
• Ensure readiness for internal and external audits; support audit execution and timely resolution of findings.
• Contribute to continuous improvement across quality processes, manufacturing practices, and documentation standards.
• Provide strong leadership to quality and production teams, ensuring clear guidance and performance oversight.

Competenze ed esperienza

• Bachelor's degree in engineering, life sciences, or related field.
• Minimum 8 years of experience in quality management within the medical device industry.
• Proven experience in managing cross-functional teams in a regulated manufacturing environment.
• Experience with EtO sterilization process and related validation activities.
• In-depth knowledge of EU MDR 2017/745, ISO 13485, FDA 21 CFR Part 820, MDSAP, and risk management (ISO 14971).
• Experience with QMS implementation, maintenance, and improvement.
• Strong problem-solving skills and experience with tools : 8D, Fishbone, FMEA, etc.
• Excellent communication, organizational, and leadership skills.
• Excellent written and spoken English.

Completa l'offerta

Permanent contract

(Milano)