Quality Manager – medical devices

Job title:

Company:

Michael Page

Job description

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.

MilanoQuality Manager

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.

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.Permanent contract(Milano)