Senior Manager QA Software Compliance (f/m/d)

QIAGEN GmbH

40724 Hilden - Deutschland

Mikrobiologe/-biologin Arbeit Vollzeit ab 01.10.2025

Beschreibung

Position Description

We are seeking an experienced and motivated professional to join our software quality assurance team. In this key role, you will help ensure compliance with IVDR, FDA 21 CFR Part 820, and cybersecurity requirements for medical device software.

- Partner with development teams to support compliance with internal procedures and external regulations

- Review and approve software development documentation in international, cross-functional project teams

- Safeguard adherence to Design Controls and regulatory requirements

- Identify and address deviations, support corrective actions, and promote continuous process improvement

- Conduct internal software audits and contribute to audits/inspections by regulatory authorities

Position Requirements

- Degree in computer science, bioinformatics, biology, or a related field – or 5+ years of relevant professional experience

- At least 5 years in software lifecycle management within the medical device or IVD industry

- Solid knowledge of quality management systems and standards (IEC 62304, IVDR, FDA 21 CFR 820, ISO 14971)

- Experience with cybersecurity compliance (FDA premarket guidance, EU MDR/IVDR expectations)

- Proficiency with tools such as JIRA and Polarion

- Strong English skills; German is an advantage

Quelle: Bundesagentur für Arbeit - Rechtliche Hinweise zur Nutzung
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