Quality Specialist III - QA CAPA (4089)

Organization
QIAGEN
Job Location
Germantown, MD 20874
Job Description

The Quality Specialist III is responsible for executing the Deviation/Nonconformity and Complaint Handling Processes within the Quality System. The QS III works on complex issues in which analysis of situations or data requires an in-depth evaluation of various factors. The QSIII exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. The impact of errors in the QS III position is high. Errors could result in recall of products from the field or citations for regulatory noncompliance.
- Implements and monitors systems in support of FDA regulations and ISO standards, participating in and/or leading product/process investigations, and conducting in-depth product/process analysis.
- Writes and/or analyzes reports and recommends corrective actions for QIAGEN processes and products.
- Services as a resource for staff across all departments at QIAGEN on issues pertaining to product quality and will spend a significant amount of time directly interacting with staff across all departments at QIAGEN.
- Responsible for ensuring on-going compliance to applicable quality and EHS regulations and standards.

Requirements

- BA/BS or equivalent scientific experience.
- 3 years minimum of Quality Assurance experience.
- 3 years minimum of FDA industry experience.
- ISO 13485 experience.
- Knowledge of cGMP and QSR's.
- Medical device experience is a plus.
- Must be very detail oriented.

How to Apply

If interested, please apply online at www.qiagen.com/careers, requisition ID # 4089

About Our Organization

As the innovative market and technology leader, QIAGEN creates sample and assay technologies that enable access to content from any biological sample.

Our mission is to enable our customers to achieve outstanding success and breakthroughs in life sciences, applied testing, pharma, and molecular diagnostics. We thereby make improvements in life possible.

Our commitment to the markets, customers, and patients we serve drives our innovation and leadership in all areas where our sample and assay technologies are required.

The exceptional talent, skill, and passion of our employees are key to QIAGEN’s excellence, success and value.

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