Quality Engineer required for leading Life Science Company
- Quality Engineer
- Rockville, MD
A leading Life Science company is seeking a Quality Engineer to lead their ever-growing team. Do you have Biotech, Medical Device, or Diagnostic experience, or enjoy planning and directing events involved with development, application and maintenance of quality standards for processes, materials and products? Are you a problem solver? If you answered yes to any of these questions, enjoy being part company with a steady path of evolution and are looking to take your career to the next level, then apply now!
This Quality Engineer will be responsible for management of the Change Request & Change Order (CRCO) process for new products, supporting cross-functional teams and configuration management staff to ensure all supporting information such as specifications, bills of materials, routers, verification and/or validation data, labeling, etc. are presented preceding the implementation of new product releases. This position is also accountable for guaranteeing compliance with corporate guidelines and the company's active regulatory certifications.
The Quality Engineer will be responsible for:
- New Product Development/Design Control and Quality System Execution
- Directing and/or participating in product development teams and implementation of quality principles
- Auditing new product design history files
- Assisting in development, execution, and maintenance of a Quality System compliant with active regulatory certifications.
- Participating in departmental meetings to offer contribution into the design and implementation of product quality planning systems and procedures.
- Supervising the CRCO process from submission to closure
- Ensuring that all mandatory configuration activities are appropriately completed prior to submission of documentation for change control.
The Quality Engineer should have the following skill set:
- Bachelor's degree in a technical/scientific/engineering field is required.
- 3 - 5 years of experience in biotechnology, medical devices, in vitro diagnostics, pharmaceuticals or related industry is preferred.
- Knowledge of ISO 9001 standards
- Familiarity with FDA's Quality System requirements (QSR) and ISO 13485 is preferred.
- ASQ Certification (CQE, CRE, CQA) is preferred.