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.

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.