Quality Manager

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

We are seeking an experienced Quality Manager to lead our Quality Management System (QMS) within a regulated medical device manufacturing environment. This role is responsible for ensuring compliance with regulatory and customer requirements, driving continuous improvement, and serving as the key authority for product quality, patient safety, and regulatory compliance.

Our client is a leading industrial group with a strong international presence, specializing in the development and manufacture of high-precision components and assemblies for demanding sectors such as aerospace, defence, medical devices, electronics, and industrial applications.

Description

• Lead and continuously improve the QMS in accordance with ISO 13485, regulatory requirements, and customer expectations.
• Manage quality performance, KPIs and management reviews.
• Oversee customer complaints, nonconformities, CAPA, root cause investigations, and risk management activities.
• Authorize product release and disposition of nonconforming products.
• Act as the primary quality contact for customers, suppliers, auditors, certification bodies, and regulatory authorities.
• Provide quality oversight during industrialization, process validation, and product transfer activities.
• Manage internal, customer, supplier, and certification audits and ensure timely closure of findings.
• Lead and develop the Quality team while promoting a culture of compliance and continuous improvement.
• Support Environmental, Health & Safety and Information Security requirements.

Profile

• Bachelor's Degree in Engineering or a related field;
• Experience in a Quality Management role within medical device manufacturing;
• Experience in plastic injection moulding;
• Experience in cleanroom environments, CAPA, nonconformity management, and audit management;
• Experience interacting with customers, suppliers, certification bodies, and regulatory authorities;
• Strong knowledge of ISO 13485, ISO 9001 and GMP requirements;
• FMEA, Plans, MSA, PPAP, and risk management methodologies;
• Knowledge of dimensional control, metrology, process validation, and process capability analysis;

Job Offer

• Competitive salary and benefits package.
• Opportunity to join a growing international industrial organization.
• Challenging role with a high level of responsibility and autonomy.
• Exposure to complex engineering and manufacturing projects.