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Urgent! Senior Manager QA Software Compliance (f/m/d) Job Opening In Hilden – Now Hiring QIAGEN
Overview
At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible.
We’re dedicated to revolutionizing science and healthcare for the better.
From our entrepreneurial roots to our current global presence, we've grown into a force for positive change.
With thousands of employees across six continents, collaboration is our greatest strength.
We’re always striving to identify talented individuals to join our exceptional teams.
We have played a pivotal role in shaping modern science and healthcare, and we're just getting started.
If you're someone who thrives on new challenges and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.
At QIAGEN, every day is an opportunity to make a real-life impact.
Join us, grow with us, and together, let's shape the future of biological discovery.
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
What we offer
- Holiday pay as well as additional days off on Christmas Eve, New Year's Eve & Carnival Monday
- Hybrid working (depending on your role)
- Bicycle leasing
- Gym & free sport classes
- Company pension scheme & employer contributions to a savings plan
- Subsidized lunch
- Possibility for childcare for children under 3 (QIAkids)
- Internal training opportunities
- Free parking
- Employee Assistance Program and internal QIAGEN communities
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.
We cultivate a collaborative, supportive environment where each individual and team can flourish.
We champion accountability and encourage entrepreneurial thinking.
QIAGEN is committed to creating an inclusive environment and is 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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Unlock Your Senior Manager Potential: Insight & Career Growth Guide
Real-time Senior Manager Jobs Trends in Hilden, Germany (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Senior Manager in Hilden, Germany using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 69202 jobs in Germany and 37 jobs in Hilden. This comprehensive analysis highlights market share and opportunities for professionals in Senior Manager roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! QIAGEN is currently hiring and seeking a Senior Manager QA Software Compliance (f/m/d) to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Senior Manager QA Software Compliance (f/m/d) Jobs Hilden.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at QIAGEN adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Senior Manager QA Software Compliance (f/m/d) Jobs Germany varies, but the pay scale is rated "Standard" in Hilden. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Senior Manager QA Software Compliance (f/m/d) typically include Computer Occupations and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your Senior Manager QA Software Compliance (f/m/d) interview at QIAGEN, research the company, understand the job requirements, and practice common interview questions.
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