Quality Assurance Specialist

• Coordinate and execute the regional Quality Compliance program across EMEA
• Develop and maintain the annual EMEA internal audit program based on risk, regulatory requirements, and business priorities
• Plan, conduct, document, and report internal audits across EMEA locations and functions
• Monitor audit findings and support site management with timely implementation and closure of CAPAs
• Coordinate and support notified body, certification body, customer, and regulatory audits and inspections
• Prepare and consolidate Management Review inputs and reports
• Analyze quality metrics and trends to support Management Review discussions and decision-making
• Support maintenance and continuous improvement of the Quality Management System
• Provide guidance on quality compliance requirements, audit readiness, and best practices
• Support CAPA management, quality risk management, document control, change management, training compliance, and quality reporting
• Collaborate with regional and global Quality teams to align compliance initiatives and quality objectives
• Promote a culture of quality, compliance, and continuous improvement

• Bachelor's degree in Life Sciences, Engineering, Quality Management, or a related discipline
• Minimum 3–5 years of experience in Quality Assurance, Quality Compliance, or Quality Systems within a regulated industry
• Experience in Medical Devices, Pharmaceutical, Biotechnology, or similar regulated industries
• Experience planning and conducting internal audits
• Experience supporting external audits and regulatory inspections
• Experience preparing management review materials and analyzing quality metrics
• Strong knowledge of Quality Management Systems and applicable regulations and standards, including ISO 13485, FDA QSR, and MDR or equivalent
• Certified Internal Auditor qualification preferred
• Fluent in English; additional European languages are an advantage
• Ability to travel within the EMEA region as required

• Comprehensive Total Rewards program
• Reward and recognition opportunities
• Competitive compensation and benefits programs
• Learning, growth, and development opportunities
• Face-to-face collaboration culture supporting learning, progress, and success