QA Medical Device Expert

Job Description Summary

QA Medical Device Expert (d/f/m) | Kundl, Austria

Job Description

QA Medical Device Expert (d/f/m) | 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.

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)
• Subsidized meals in our canteen
• Sustainable mobility in the form of company transportation, shift buses and car sharing
• Company Kindergarden 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, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 65.605,54/year (on a full-time basis).

In most cases, however, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged

Are you ready to join us? Then we look forward to your application

Commitment to Diversity & Inclusion:

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 .

#Sandoz

Skills Desired

Auditing, Compliance Risk, Data Analysis, Operational Excellence, Regulatory Compliance, Regulatory Reporting

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