QA Medical Device Expert

QA Medical Device Expert

Sandoz

Kundl, Austria

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!

Your Key Responsibilities:

Your responsibilities include, but are not limited to:

• Oversee the release and quality compliance of medical devices and combination products at the site.
• Review and approve deviations, OOS cases, complaints, and CAPAs related to medical devices, ensuring regulatory alignment (GMP, MDR, MDSAP).
• Support and evaluate Change Control processes and ensure effectiveness of corrective actions.
• Ensure data integrity for medical device-related systems and documentation; implement internal standards and conduct training.
• Maintain and monitor risk management activities for medical devices, including documentation and mitigation strategies.
• Review and maintain QA-relevant material master data in SAP for medical device articles.
• Approve GMP documentation and batch records specific to medical devices, ensuring compliance with internal and external requirements.
• Support audits and inspections; contribute to continuous improvement of the quality system and cross-functional collaboration.

What you’ll bring to the role:

Essential Requirements:

• Bachelor’s or Master’s degree in a scientific, technical, or pharmaceutical discipline.
• 3–5 years of experience in the medical device industry, preferably within a GMP-regulated environment.
• Solid knowledge of relevant ISO standards, especially ISO 13485.
• Experience with EU MDR and MDSAP compliance.
• Proven involvement in audits or inspections with Notified Bodies (e.g. TÜV).
• Familiarity with deviation, complaint, CAPA, and Change Control processes.
• Ideally experience working in a matrix organization with cross-functional collaboration.
• Proficiency in SAP and electronic quality systems; strong documentation and data integrity skills.
• Excellent communication skills and ability to work effectively across departments and sites.