Senior Specialist, Quality Management

vor 1 Woche

München, Deutschland AstraZeneca Vollzeit

**ABOUT ASTRAZENECA**

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

**SITE DESCRIPTION - Munich, Germany.**

Welcome to Computational Pathology Munich, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you: After-work events, lunch & learns, spacious environment, sustainable office working environment, events, family and childcare support and of course the Alps around the corner for hiking, biking and skiing.

**BUSINESS AREA**

From diagnosis to later stage development, we’re laser-focused on leading the way forward to create solutions that transform lives. We are focused on identifying and treating patients earlier, where there is greater curative potential. With the greatest number of early-stage cancer trials in the industry, we are getting closer to finding cures every day.

**What you’ll do**
- Support the implementation of a QM system that complies with EN ISO 13485:2016 for medical device software.
- Define and improve processes by creating/updating SOPs, forms and templates to ensure conformity with applicable internal and external requirements.
- Deliver trainings on SOPs and applicable standards.
- Quality Assurance of software development process to ensure compliance with IEC 62304, international AI standards and internal processes.
- Write and contribute to product technical documentation.
- Support preparation of internal and external quality audits.

**Essential for the role**
- Degree in engineering, natural sciences, computer science or related discipline, or 3 years of equivalent working experience.
- At least 4 years of relevant work experience in the medical device industry with focus on quality and regulatory topics, and 2 years in SaMD (Software as a Medical Device) design and development.
- Good knowledge of relevant norms and regulations for SaMD (ISO 13485, IEC 62304, ISO 14971).
- Excellent written and verbal communication skills in English and an eye for detail.
- Ability to drive, influence, manage, execute, and deliver results for complex multi-functional, interdisciplinary projects.

**Desirable for the role**
- Experience with In-vitro Diagnostics medical devices (IVD) and understanding of IVD performance evaluation.
- Understanding of drug development process and companion diagnostics.

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