Scientist, Quality Assurance

hace 6 meses

Barcelona, España Qiagen A tiempo completo

**Overview**
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 the Design QA Scientist you will represent the Quality Assurance function within local and global multidisciplinary project teams developing innovative in-vitro diagnostic (IVD) and medical device products (mainly PCR-based). You will ensure compliance to corporate procedures, government regulations, international standards and IVD industry standards. With your strong technical background you will also coach, support and challenge development teams to develop the right quality products by ensuring robust specifications, processes and methods.

Key responsibilities:

- Represent the QA department in the development and maintenance of IVD products (reagents, instruments and software)
- Collaborate with local and global multidisciplinary project teams to ensure that quality, safety, reliability and manufacturability are considered in the design phases of new product development
- Ensure rigorous adherence to Design Controls and regulatory requirements
- Proactively identify and address deviations and initiate corrective actions
- Review and approve relevant design documentation for conformance to corporate processes, international standards and IVD industry standards
- Co-operate closely with other QA teams such as operational QA or CAPA QA
- Participate in product & project risk analyses
- University degree with a proven scientific background, e.g. in biology, chemistry or biochemistry, preferably with a doctorate
- Profound knowledge and practical experience in the field of molecular biology essential
- Ideally experience in the development of medical or IVD products and familiarity with relevant standards (IVDR Regulation (EU) 2017/746 and FDA 21 CFR.820)
- Fluency in written and spoken English
- A friendly team player with the ability to communicate and collaborate with cross-functional teams both confidently and convincingly
- Excellent problem solving and decision-making skills combined with good reasoning and judgment skills to ensure the appropriate balance of quality, compliance, and business needs.

**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: EMEA04462

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