Quality Assurance Leader – Eastern, Southern Europe

Role Overview

• Acting as the focal point for QA in Eastern & Southern Europe, supporting Sales, Service, and Operational teams.
• Participating in the maintenance and updating of the QMS, including Site Quality Plans (SQPs), local procedures, and training compliance.
• Ensuring understanding and adherence to quality procedures across the Region.
• Leading and supporting internal and external audits, including regulatory inspections.
• Monitoring and reporting on QMS training status; co-accountable for training completion in the zone.
• Coaching and mentoring teams on the development, maintenance, and simplification of local procedures.
• Providing guidance to business managers on quality topics and regulatory expectations.
• Driving the CAPA process by identifying quality concerns, conducting spot audits, and ensuring timely corrective actions.
• Facilitating regional response to urgent reportability clarification requests raised by the Complaint Handling Unit.
• Leading or supporting quality improvement projects and QPTPs (e.g., repair center setup, office moves, harvesting).
• Managing deviation/concession processes and ensuring compliance with tool calibration and OOT requirements.
• Supporting channel partner quality oversight, including Annex Q adherence and audit readiness.
• Collaborating with the Supplier Quality team to ensure use of qualified suppliers.
• Supporting closure of customer complaints, field actions, and non-conformances.
• Participating in remote internal audits as lead auditor or SME.
• Collaborating with the regional RA team to ensure alignment on regulatory requirements, audit readiness, and product compliance.
• Representing Eastern & Southern Europe in INTERNATIONAL region and global QA forums and initiatives.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field.
• Experience in Quality Assurance within the medical device, healthcare, or regulated industry.
• Strong knowledge of ISO 13485, EU MDR, and other applicable international regulations.
• Experience in internal and external audits, including regulatory inspections.
• Proven ability to manage QMS documentation, training, and compliance activities.
• Excellent English communication skills (written and spoken).
• Strong organizational, analytical, and leadership skills.
• Ability to work and to travel independently and collaboratively across diverse cultures and geographies.

Benefits

• Health & wellness coverage
• Retirement and or savings plans
• Allowances or benefits to support role requirements (e.g., mobility, transport, or role-specific needs such as a company car or allowance where applicable)
• Work-life balance support (e.g., flexible working, leave programs)
• Recognition and incentive programs aligned with performance and company success