Quality Engineer (m/f/d)

For our client Envirotainer, a global leader in temperature-controlled pharmaceutical logistics equipment, we are seeking a Quality Engineer (m/f/d) for their Frankfurt am Main location. Envirotainer is a global leader in temperature-controlled logistics equipment for pharmaceuticals, ensuring the safe and reliable transport of life-saving medicines worldwide. With over 40 years of industry experience, the company partners with leading pharmaceutical organizations to provide innovative cold chain solutions, supported by advanced shipment monitoring and a robust global network.

A strong focus on sustainability is reflected in science-based targets aimed at reducing emissions across both its own operations and those of its customers. Through a transparent, data-driven approach, environmental impact is continuously measured and improved.

Covering the entire pharmaceutical lifecycle—from research and development to commercial distribution—the company delivers equipment to enable shipments ranging from large-scale volumes to individual patient samples, ensuring the safety and efficacy of medicines at every stage.

• The overall responsibility of this role is to maintain and further develop the Quality Management System (QMS) in line with applicable company standards, regulatory and accreditation requirements (e.g. ISO 9001), and customer expectations.
• Administer and continuously improve the internal electronic Quality Management System Ideagen Quality Management IQM , acting as a key super user.
• Ensure effective management of CAPA and document control processes.
• Oversee the change management system, ensuring all changes are properly documented, assessed, and implemented.
• Conduct internal and external audits to identify quality issues and drive continuous improvement.
• Support regulatory and accreditation inspections and client audits across multiple sites across Europe and globally.
• Collaborate with operational teams to establish and maintain procedures, standards, and systems.
• Build strong relationships with site personnel and provide training and guidance on quality processes and procedures.
• Generate eQMS reports and prepare documentation for management review meetings.
• Willingness to travel up to approximately 20% to support sites across Europe and globally.

• Bachelor’s or Master’s degree in a relevant field such as Engineering, Chemistry, Biotechnology, Pharmaceutical Sciences (or equivalent qualification).
• Minimum of 2 years’ experience in a production, QA, or QC environment within a highly regulated industry.
• Solid understanding of regulatory requirements and quality standards (e.g. ISO 9001, Part 145, Part 21G/21J, EU/US BASA).
• Hands-on experience with electronic Quality Management Systems (eQMS).
• Fluency in German and English, both written and spoken.
• Experience with CEIV and GDP guidelines is considered an advantage.
• Proficient in Microsoft Office, particularly Outlook, Word, and Excel.
• Strong communication skills, both written and verbal.
• Ability to work independently and solve practical problems in a flexible and solution-oriented manner.
• High level of accuracy with strong attention to detail.
• Ability to build and maintain effective relationships with key stakeholders.
• Team player with a collaborative mindset.
• Flexible and adaptable in a dynamic, international business environment.