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 5000 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 and international, 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

The Senior Quality Engineer (Contractor) position in the Department of Design and Change Control QA is responsible for providing quality assurance support to cross-functional project teams that drive the design, development, commercialization, and lifecycle management of in vitro diagnostic (IVD) products and their manufacturing methods. The position is responsible for ensuring that all aspects of projects are in compliance with applicable standards and regulations for Design Control and Risk Management.

Position Requirements

- BS or higher in a scientific/engineering discipline, CQE and ISO lead auditor certification a plus.

- 8 years' experience in biotech industry, preferably FDA and/or ISO in a QA or scientific role.

- Working knowledge of validation, design control/product development, GMP and general QA, preferred but not required.

- Knowledge of computer systems validation in a regulated environment preferred.

Personal Requirements

- Able to maintain a professional environment and act in accordance with company policies, guidelines, and generally-accepted norms.

- Able to operate independently under general direction.

- Able to work closely with departments involved in product and process development (e.g. development, operations, regulatory affairs, marketing), and sustain productive relationships at all levels within these and other departments.

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, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.

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