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 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 Design Quality Assurance Engineer will report to the Sr. Design Quality Assurance Engineer. S/he represents Design Quality Assurance within cross-functional teams to coordinate documentation and ensure compliance for instrument IQ/OQ, assay Verification/Validation activities and Risk Management. Position responsibilities also include monitoring Engineering Change Controls and data trending to provide corrective action solutions that drive continuous improvement. Assurance

Job performance will involve a variety of activities including:

-Review of a range of Design Control documentation for new IVD developments including protocols and reports for compliance with internal SOPs and external standards.

-Participation in Design Reviews and Risk Management activities and support of internal and external stakeholders with QA guidance and advice as required

-Review and approve equipment IQ/OQ and assay Verification/Validation studies in collaboration with cross-functional teams.

-Review and approves change control related documentation required for ECR/ECN.

-Review and approval of SOPs and maintenance of elements of the Quality Management System .

-Work in collaboration with product development to ensure that the designs, procedures and outcome of the project are acceptable in quality.

-Applies statistical methods for analyzing data to evaluate the current process and process changes and solve problems.

-Maintains a working knowledge of industry standards. Knows and follows the ISO quality system guidelines.

-Additional responsibilities may be assigned as needed.

Position Requirements

-A Bachelor’s degree in Engineering related field or related discipline, or equivalent experience.

- Employment experience within regulated industry including a working knowledge of Design Control and IVD development essential. Exposure to relevant regulations including ISO 13485, 21 CFR 820, MDSAP.

- Experience specifically within a QA role is desirable but not essential as long as you fulfill the above requirements and are keen to move into a more QA-focused role.

Personal Requirements

-Excellent communication skills with the ability to contribute and collaborate as part of a multifunctional and multinational team to meet deadlines on multiple projects simultaneously

QIAGEN requires proof of full COVID-19 vaccination as a condition of employment for new hires in all U.S. states other than Montana effective as of September 1, 2021. New hires and candidates will be required to present proof of full COVID-19 vaccination within three business days of start date or upon entry into the office (i.e., for interviews), whichever comes first. QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact benefits. This policy is part of QIAGEN’s ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.

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.

Job Type: Contract

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person

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