Quality Assurance Manager

We are looking for a Quality Assurance (QA) Manager to join our team to maintain and continuously improvement our Quality Management System (QMS).

This position is ideal for a detail-oriented professional with 2–3 years of experience in a highly regulated quality role who thrives on systematic order, precision, and cross-functional collaboration.

Key Responsibilities

• QMS Maintenance and compliance: Support the maintenance, implementation and continuous improvement of the Quality Management System (QMS) in accordance with ISO 13485 and EU MDR
• Batch Record Review and Release: Perform detailed reviews of production batch records and laboratory data. Authorize the formal release of finished goods (Batch Release) to the market
• CAPA and non-conformance administration: Own and administer the non-conformance (NC) and corrective and preventive action (CAPA) systems. Review root-cause analyses provided by engineering and verify the long-term effectiveness of implemented solutions
• Risk Management and ISO 14971 Compliance: Oversee and maintain the Risk Management File in strict accordance with ISO 14971 standards and ensure that all risk assessments (including dFMEA and pFMEA) are regularly reviewed, updated and aligned with regulatory requirements
• Document and Change control management: Manage and approve Standard Operating Procedures (SOPs), work instructions and technical specifications. Review and approve engineering change controls
• Auditing: Conduct internal QMS audits across all departments. Participate actively in preparing the facility for external certification audits (Notified Bodies, CE marking) and customer inspections
• Complaints Handling: Investigate customer complaints, coordinate technical investigations with the production floor and draft official safety/investigation reports
• Support in the transition from MDD to MDR
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Candidate Profile

• Education: Bachelor’s degree in engineering (Biomedical, Chemical, Industrial, Mechanical), Pharmacy, Biology, or related scientific discipline
• Experience: Minimum 2–3 years of experience in a Quality Assurance role within a highly regulated industry
• Direct experience with ISO 13485, ISO 14971, or GMP (Pharmaceuticals) is highly preferred
• Skills: Excellent understanding of QMS structures, document control and auditing techniques
• Languages: Fluency in English (written and spoken) is mandatory for managing medical documentation, group communication and external audits
• Detail-oriented & analytical person, organized and responsible, assertive communicator (ability to present complex quality requirements clearly and collaborate with the team)

What We Offer

• Structured onboarding and continuous learning
• Opportunity to professional growth and career development
• Stable position in a specialized healthcare sector
• Supportive and professional working environment
• Opportunity to travel internationally and contribute to global projects

Please submit your CV in English.