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At the heart of QIAGEN’s business is a vision to make improvements in life possible.
We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees – more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic, international and diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.
Join us. At QIAGEN, you make a difference every day.
Position Description
As Senior Manager/ Associate Director QA, Medical Device Software Compliance you will work with key stakeholders to ensure that QIAGEN processes, applicable regulations and standards are followed throughout the software lifecycle process. In this position you will be active in local and global multidisciplinary project teams developing software for innovative in-vitro diagnostic and Medical Device products.
Key responsibilities:
- Coach and support development teams in order to comply with internal Software Lifecycle procedures as well as external regulations
- Ensure rigorous adherence to Design Controls and regulatory requirements
- Proactively identify and address deviations and initiate corrective actions
- As a core team member of software development projects, review and approve the software development documentation for compliance and business excellence
- Actively support the continuous improvement of the corporate software process in order to ensure that it meets international requirements
- Collaborate with development and support teams to resolve quality issues and improve product quality
- Execute internal audits as well as audits of external software service providers
- Participate in audits and inspections by regulatory authorities
Position Requirements
Degree in computer science, bioinformatics, biology or a related field, alternatively 5+ years of professional experience in the same fields
- Minimum 5 years’ experience within the Medical Device industry and in the development of Software in or as a Medical Device (SaMD)
- Strong knowledge of quality management systems and regulatory requirements related to the lifecycle of SaMD (in particular IEC62304, IVDR, FDA 21 CFR 820, ISO 14971)
- Proficient in using tools like JIRA, Polarion
- A friendly manner and able to communicate and collaborate with cross-functional, international teams
- Exceptional problem-solving and analytical skills with the ability to contribute effectively to multiple projects
If this challenging, interdisciplinary field of activity appeals to you, a highly motivated team awaits you at QIAGEN, which is looking forward to your support - we look forward to your application!
What we offer
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
QIAGEN is committed to creating a diverse 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.
Job Reference: EMEA04279
