QA Engineer II

Ampcus - Chantilly, VA

Full-time - Mid Level

Remote - Chantilly, VA

Professional, Scientific, and Technical Services

About the position

The QA Engineer II position at Ampcus, Inc. involves administering a compliant and effective Quality Management System (QMS) for various activities, particularly in the medical device sector. The role focuses on the transition and deployment of the PQMS, ensuring that audit planning and scheduling meet internal policies and external regulations. The engineer will manage local QMS documents, support training initiatives, and contribute to the availability of metrics to measure training effectiveness and QMS compliance. This position requires interaction with various stakeholders and the ability to resolve issues through analysis and judgment within defined procedures.

Responsibilities

• Administer a compliant and effective QMS for the activities in scope.
• Enable the transition and deployment of the PQMS and manage its deployment.
• Ensure proper audit planning and scheduling meets internal policies and external regulations.
• Manage the plan for all QMS parts in scope while maintaining a compliant and effective local QMS during the transition to the PQMS.
• Administer and contribute to the management of local QMS documents in line with the evolution of the PEQS and PQMS.
• Support training and training administration related to the QMS and contribute to training content for local QMS documents as necessary.
• Provide metrics and KPI data to measure training effectiveness, PQMS deployment, and QMS compliance.
• Interact with subordinate supervisors and functional peer groups to gain cooperation and conduct presentations of technical information regarding projects or schedules.
• Exercise judgment within defined procedures and policies to determine appropriate actions.
• Provide direct supervision to professional individual contributors and/or skilled support personnel.

Requirements

• Minimum of three years of similar work experience in a regulated industry.
• Experience working with automated technology and business application implementation projects.
• Familiarity with process management methodologies and practices.
• Working knowledge of company products and services.

Nice-to-haves

• Prior experience with Philips Medical Devices.
• Experience with 21 CFR and ISO 9001 standards.
• Experience in medical device documentation and QA planning.

Benefits

• Remote work flexibility
• Opportunity to work in a disciplined regulated industry
• Professional development opportunities