Your responsibilities

• 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.

Our requirements

• Minimum 5 years of quality engineering experience in a regulated industry, preferably in medical devices or life sciences - required.
• Demonstrated ability to manage quality claims, supplier issues, and complaint investigations with professionalism and clarity.
• Proven experience working directly with international vendors, external stakeholders, and cross-functional teams.
• Hands-on experience with audits, CAPA, non-conformance investigations, and QMS documentation.
• Familiarity with manufacturing process validation and quality control procedures.
• Strong analytical and problem-solving skills, including root cause analysis tools
• Excellent verbal and written communication skills in English; confident interacting with external and internal partners.

Optional

• Degree in engineering, biotechnology, life sciences, or a related technical field – alternatively experience in a similar position

What we offer

• Opportunity to develop in a dynamic medical startup.

• 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 😊