1510 IT & Softwareentwickler Stellenangebote in Deutschland

QIAGEN GmbH jobs

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

65.000 - 95.000 €
QIAGEN GmbH
Qiagen Straße 1, Hilden
65.000 - 95.000 €
Unternehmensgrösse icon
Unternehmensgrösse
5k+
Unternehmenstyp icon
Unternehmenstyp
Product
Erfahrungsstufe icon
Erfahrungsstufe
Senior
Anstellungsart icon
Anstellungsart
Vollzeit
Sprache icon
Sprache
Deutsch
Visa Sponsoring icon
Visa Sponsoring
Nein

Anforderungen

Muss:
- 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

Technologien

Verantwortlichkeiten

- 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

Beschreibung


At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. We dedicate ourselves to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we have grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We have played a pivotal role in shaping modern science and healthcare, and we’re just getting started. If youre someone who thrives on new challenges and wants to make a tangible difference in people’s lives, then QIAGEN is the place for you. Every day here is an opportunity to make a real-life impact. Join us, grow with us, and together, let’s shape the future of biological discovery. We offer holiday pay along with additional days off, hybrid working options (depending on your role), bicycle leasing, gym memberships, and free sport classes. We also provide a company pension scheme, subsidized lunch, childcare possibilities for children under 3 (QIAkids), internal training opportunities, and free parking. Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. At QIAGEN, we cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking. Furthermore, we are committed to creating an inclusive environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.
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