Senior Quality Engineer

The Quality Engineer II will support business operations at the Columbia, MD site by maintaining critical management systems and assuring the efficacy of established process control programs, including calibration and maintenance, change management, validation, environmental monitoring, and others.

DESIRED MINIMUM QUALIFICATIONS

• Education : Bachelor of Science or higher; Master’s degree is preferred. Education requirements can be reduced considering years of experience in a relevant role.
• Certifications : American Society for Quality (ASQ) or Regulatory Affairs Professionals (RAPS) certificates or similar are preferred. Candidates who are not certified must demonstrate technical competency by obtaining a relevant certification from an accredited certification organization, college, or university within the first year of employment.
• Experience : Technical specialization in change management and data integrity, systems development/validation, or data integration/trending.
• Demonstrates an understanding of statistically-based sampling plans, application of analytical tools, and has a history of data driven decision-making.
• Demonstrates excellent organizational, communication, and project management skills. Produces high-quality work in a timely manner. Able to prioritize projects to meet organizational goals and objectives
• Demonstrates knowledge of the principles of data integrity. Coding/scripting proficiency and/or experience validating complex data management networks is desired.
• Is well informed and proficient in the use of modern technology, especially electronic quality management systems, enterprise resource management systems, and the Microsoft suite of applications.
• Must be able to work independently with minimal supervision.
• Knowledge of international standards and maintaining the currently recognized state-of-the-art