Quality Engineer II
- Greater Baltimore area
A leader within the manufacturing and commercialization of innovative instruments used for measurements of molecules in biological samples is actively seeking a Quality Engineer II to join their growing team. This role is responsible for participating in New Product Development projects while serving as the representative for multiple quality activities.
Main Responsibilities:
- Ensure compliance to QMS procedures and providing guidance to project teams
- Develop validation protocols, preparing documentation, and make recommendations for changes and improvements
- Participate in internal and supplier audits, while ensuring audits are performed, documented, and completed according to schedules
- Oversight of CAPA and QMS continuous improvement projects, analyzing metrics to measure effectiveness
- Manage both design history and risk management files
Desired Qualifications:
- Bachelor's degree in a scientific or engineering discipline
- 5+ years of medical device, pharmaceuticals, or related industry experience
- ASQ Certification a plus
- Working knowledge of cGMP, ISO, and other international regulations
- Ability to organize and move project tasks following set timelines
