QA Medical Device Expert (d/f/m) | Kundl, Austria – Sandoz Österreich
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 all of us, both professionally and personally. Join us – the future is ours to shape!
Your Key Responsibilities
* 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.
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.
You’ll Receive
* Attractive salary with incentive program
* Modern company pension scheme
* Flexible working hours / home‑office depending on the position
* 14 weeks of paid parental leave
* Additional days off (bridge‑days)
* Subsidised meals in our canteen
* Sustainable mobility in the form of company transportation, shift buses, and car sharing
* Company kindergarten and summer camps for children
* Wellbeing & mental health offers
* Learning and development options for your personal and professional growth
* Worldwide career opportunities
In accordance with Austrian law, the minimum salary for this position is EUR 65,605.54 per year on a full‑time basis. The actual salary may be higher, reflecting your experience, qualifications, and competencies.
We are committed to building an outstanding, inclusive work environment and fostering diverse teams that represent the patients and communities we serve. If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at jobs.austria@sandoz.com.
Are you ready to join us? Then we look forward to your application!
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