QA Specialist, Device History Record Review at QIAGEN in Ann Arbor, Michigan

Job Description:

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 DHR Specialist will be an active member of the Quality team within the manufacturing environment. He/she will primarily be responsible for the review and approval of DHRs, often performing reviews in real time (on the manufacturing floor). Additional administrative duties may be required to assist the Quality department.

Role and Responsibilities:

- Review and approve DHRs for Instruments, Components, Accessories and packaging, for compliance to product specifications and internal traceability requirements
- Create certification documents and authorize release of product shipments for distribution to customers
- Ensure any non-conformances and deviations are properly approved and documented in the DHR
- Work collaboratively with manufacturing to resolve any DHR issues in a timely manner
- Perform administrative duties as they pertain to DHRs (scanning, filing, organizing records)
- Perform label verification prior to release of work orders
- Report discrepancies through the appropriate QMS processes
- Assist with discrepancy evaluations and work with the department on process improvements
- Must be able wot work with all levels of associates within the organization
- Adhere to local and global policies and procedures as applicable

Position Requirements

- Minimum 3 years of experience performing DHR reviews and QA shipping and release activities for medical device products
- Minimum 5 years of experience in an ISO 13485 and/or FDA 21 CFR 820 (medical device) regulated industry
- Well versed in Good Documentation Practices
- Proficient in Microsoft Office applications (primarily MS Word and basic Excel, Adobe )
- Must be detail-oriented with strong written and verbal communication skills

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.

.