Production Quality Engineer

Our client is an international company in the medical device sector, operating in a highly regulated environment (cGMP). In this context, they are seeking a Production Quality Engineer to strengthen their Quality team.

The Quality team is responsible for the operation and maintenance of the elements and tasks of the quality management system (QMS) directly related to the products. Its main role concerns material management: it ensures that the compliant release of all raw materials and materials in process, as well as finished products, is carried out according to the required schedule to support the company’s overall operations.

Compliant release is defined as the guarantee that materials are safe and effective and pose no risk to patients, end users, or internal manufacturing and control processes. This involves compliance with all regulatory requirements and current good manufacturing practices (cGMP).

Job Purpose

The Production Quality Engineer will be responsible for carrying out production quality activities related to raw materials, intermediate products, and finished products, in accordance with operational objectives, legal and regulatory requirements, and the principles of current good manufacturing practices (cGMP).

The post holder will have knowledge of our processes, products, and equipment and their application, as well as the standards and regulations applicable to the quality management system. This knowledge will enable them to contribute directly to internal and external audits.

The role is strongly customer-oriented: the post holder will need to regularly collaborate with key contacts from other functions (Supply Chain, Production, Research & Development) to achieve the expected operational results and, if necessary, escalate to their line manager any priority conflicts that may arise during planned or unplanned events. This will help, as far as possible, to meet the company’s operational schedules.

Main Activities and Responsibilities

• Ensure quality release (Batch Release) of raw materials, intermediate products, and finished products, guaranteeing documentary, regulatory, and GMP compliance before their availability.

• Verify the completeness and compliance of batch records, quality records, and data in the ERP and quality management system (QMS).

• Manage non-conformities, deviations, change controls and contribute to investigations and root cause analysis.

• Participate in equipment qualification and maintain quality documentation (SOPs, specifications, supplier files, etc.).

• Monitor quality indicators, analyse trends, and propose continuous improvement actions.

• Participate in internal, client, and regulatory authority audits, as well as quality meetings.

• Ensure compliance with GMP requirements, current regulations, and health, safety, and environmental rules.

Profile Sought

• Scientific Bachelor’s degree (pharmacy, biotechnology or equivalent).

• Experience in Quality Assurance in a GMP environment, with significant experience in Batch Release.

• Good knowledge of GMP standards, ISO 13485, IVD/FDA, and quality systems.

• Proficiency in Microsoft Excel and IT tools (ERP, QMS).

• Analytical mind, rigour, organisational skills, and excellent priority management.

• Good interpersonal skills, team spirit, and ability to communicate with diverse stakeholders.

• Fluent in French and English.