Quality Manager - Medical Devices QMS & Compliance

Michael Page; Marinha Grande; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

International exposure

Autonomy in role

Challenging projects

Job summary

Michael Page is seeking an experienced Quality Manager to drive the Quality Management System (QMS) in a regulated medical device manufacturing environment. The role ensures compliance with regulatory and customer requirements, drives continuous improvement and acts as the key authority for product quality, patient safety and regulatory compliance.

The incumbent will lead the QMS, manage KPIs and management reviews, oversee complaints, CAPA, root-cause investigations and risk management, and

Qualifications

• Bachelor's Degree in Engineering or related field.
• Experience leading QMS in medical device manufacturing.
• Strong knowledge of ISO 13485, ISO 9001 and GMP requirements.
• Experience with CAPA, nonconformity management and audits.

Responsibilities

• Lead and continuously improve the QMS per ISO 13485 and regulatory requirements.
• Manage quality performance, KPIs and management reviews.
• Oversee customer complaints, nonconformities, CAPA, root cause investigations and risk management.

Skills

Quality management

Regulatory compliance

Root cause analysis

CAPA

Education

Bachelor's degree in Engineering

Job description

Michael Page is seeking an experienced Quality Manager to drive the Quality Management System (QMS) in a regulated medical device manufacturing environment. The role ensures compliance with regulatory and customer requirements, drives continuous improvement and acts as the key authority for product quality, patient safety and regulatory compliance.

The incumbent will lead the QMS, manage KPIs and management reviews, oversee complaints, CAPA, root-cause investigations and risk management, and