Quality Manager

Michael Page; Marinha Grande; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Michael Page seeks an experienced Quality Manager to lead the QMS in a regulated medical device manufacturing environment. You will ensure regulatory and customer compliance, drive continuous improvement, and serve as the authority on product quality, patient safety, and regulatory compliance.

You will manage KPIs, audits, CAPA, risk management, and supplier/auditor interactions while guiding a quality team through process validation, product transfer, and continuous improvement initiatives.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience in a Quality Management role within medical device manufacturing.
• Experience in plastic injection moulding.
• Fluent English.

Responsabilités

• Lead and sustain the QMS in accordance with ISO 13485 and regulatory requirements.
• Drive continuous improvement and manage quality performance KPIs and management reviews.
• Oversee customer complaints, CAPA, nonconformities, and risk management activities.
• Authorize product release and disposition of nonconforming products.
• Act as primary quality contact for customers, suppliers, auditors, and regulators.
• Provide quality oversight during industrialization, validation, and product transfer.
• Manage audits and ensure timely closure of findings.
• Lead and develop the Quality team and promote a culture of compliance.
• Support EHS and Information Security requirements.

Connaissances

Quality management

CAPA

Audit management

Risk management

FMEA

Client interaction

Formation

Bachelor's Degree in Engineering

Description du poste

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.

Client Details

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;
• Fluent English

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.