Quality Engineer

• Provide quality oversight and support to operational units, including a strong focus on claim management and resolution across the supply chain and in production areas, leveraging deep understanding of operational quality processes.
• Respond to customer and supplier quality claims, investigate complaints, document findings, and implement resolutions.
• Handle non-conformances, perform root cause analyses, and lead corrective and preventive actions (CAPA).
• Manage supplier qualification, evaluation, and monitoring, including conducting supplier audits and ensuring alignment with quality agreements.
• Support incoming quality control (IQC) and material release processes by establishing and monitoring inspection procedures.
• Oversee process validation (IQ, OQ, PQ) and contribute to continuous process improvements across the product lifecycle in-house and at CMOs.
• Monitor and report on quality performance metrics and trends; support quality reviews and continuous improvement initiatives.
• Represent the quality function in cross-functional meetings, technical discussions, and during external communication with international vendors and partners.
• Ensure compliance with ISO 13485, and other applicable regulations through active management of the Quality Management System (QMS).
• Maintain and update controlled documentation including SOPs, work instructions, forms, and records.
• Collaborate with R&D, regulatory, production, and supply chain teams to support product development, design transfer, and manufacturing activities.

• Opportunity to develop in a dynamic medical organisation.
• Real impact on the development of an innovative product that saves health and life.
• Collaboration with a multidisciplinary team (engineers, microbiologists, software, clinic).
• Involvement in application-oriented projects aimed at the development and commercialization of new diagnostic technologies.
• Participate in a unique antibiotic resistance project - We are creating solutions that will realistically protect the health and lives of people around the world.
• Collaboration with a wide range of leading international stakeholders.
• An atmosphere that fosters open communication and encourages growth.
• An international environment - we have 8 nationalities on board ?

• sharing the costs of sports activities
• private medical care
• remote work opportunities
• flexible working time
• fruits
• integration events
• no dress code
• coffee / tea

Bacteromic Sp. z o.o.