Title:  Quality System Manager Audit Services

Your main tasks

• Ensure compliance of QMS processes with applicable regulatory requirements (e.g. ISO 13485, EU MDR, QMSR, MDSAP and other relevant standards)
• Plan, coordinate, and manage external audits conducted by customers, regulatory authorities, and certification bodies
• Lead and conduct internal audits (as lead or co-auditor), including audit planning, documentation, audit program management, and KPI reporting
• Drive continuous improvement of QMS processes in close collaboration with global and local stakeholders
• Investigate audit findings and take ownership of defining and implementing effective corrective and preventive actions (CAPAs)
• Act as a trusted partner to business units by advising and training on QMS-related topics (e.g. IT, sustainability, change control, audit management, deviation management, documentation)
• Lead or contribute to strategic QMS projects, including certifications, implementation at new international sites, and expansion into new markets

Your profile

• At least 2 years of experience in audit and/or quality management within the life sciences sector (e.g. medical devices, pharmaceuticals, or biotechnology)
  (candidates with strong potential and relevant exposure are encouraged to apply)
• A degree in engineering, life sciences, medicine, or a related field
• Knowledge of relevant regulatory requirements (e.g. ISO 13485, EU MDR, QMSR, MDSAP, GMP)
• Experience with QMS software (e.g. TrackWise, SAP, or similar systems) is an advantage
• Strong stakeholder management and communication skills; experience working with regulatory authorities or notified bodies is a plus
• Fluent in German and English, both written and spoken (C1)