Medical Device Expert (d/f/m)

Sandoz Österreich; Kundl; Vor Ort; EUR 65 000 - 85 000; Vollzeit

Zusammenfassung

A leading provider of biosimilar medicines in Kundl, Austria is seeking a Medical Device Expert. The role involves overseeing compliance, managing audits, and ensuring data integrity for medical devices. Ideal candidates will have a Bachelor’s or Master’s degree along with 3-5 years of experience in the medical device industry. Attractive benefits include flexible working hours and a competitive salary.

Leistungen

Attractive salary with incentive program

Flexible working hours

Modern company pension scheme

14 weeks of paid parental leave

Subsidised meals

Learning and development options

Qualifikationen

• 3–5 years of experience in the medical device industry, preferably within a GMP-regulated environment.
• Familiarity with deviation, complaint, CAPA, and Change Control processes.
• Experience with EU MDR and MDSAP compliance.

Aufgaben

• Oversee release and quality compliance of medical devices.
• Review deviations, OOS cases, and ensure regulatory alignment.
• Support audits and inspections to improve quality systems.

Kenntnisse

Knowledge of ISO standards

Experience in the medical device industry

Strong documentation skills

Excellent communication skills

Ausbildung

Bachelor’s or Master’s degree in a scientific or pharmaceutical discipline

Tools

SAP

Electronic quality systems

Jobbeschreibung

Medical Device Expert (d/f/m)

Location: Kundl, Austria Sandoz Österreich – a leading provider of sustainable biosimilar and generic medicines.

Job Details

• Seniority level: Mid‑Senior level
• Employment type: Full‑time
• Job function: Health Care Provider
• Industry: Pharmaceutical Manufacturing

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.

Benefits & Compensation

• 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 the canteen.
• Company transportation, shift buses, and car sharing for sustainable mobility.
• Company Kindergarden and summer camps for children.
• Wellbeing & mental health offers.
• Learning and development options for 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, depending on experience, qualifications and individual competencies.

About Sandoz

Sandoz, a leader in biosimilar and generic medicines, provides over 800 million patient treatments to more than 700 million patients every year. 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.

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 [e-mail].

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