Job Summary:

On-site position.  The QA/RA will manage the Company’s Quality Management System (QMS) to ensure medical products meet regulatory and technical requirements.  Their duties include managing product labeling activities, overseeing prime subcontractor quality functions, ensuring the Company’s Quality Management System meets current US and European standards for medical devices. 

Responsibilities:

• Implementing and maintaining the QMS to ISO 13485 and FDA cGMP standards.
• Manage design history and risk management systems for new and existing products
• Manage change control and document control systems
• Coordinate and manage internal and external site audits
• Manage customer complaints/returns
• Manage and oversee Technical Files
• Keep up to date with changes in national and international regulatory guidelines
• Communicate directly with prime subcontractor regarding manufacturing issues relating to quality standards

Experience:

• GMP and ISO 13485 regulations.
• At least 5 years of relative quality management experience in medical device manufacturing operation
• Knowledge of FDA/ISO Regulated Medical Device Procedures
• Good communication skills and an eye for detail are required, as well as thoroughness and ability to deal with complex issues. 
• Must be a self-starter capable of managing projects from start to finish.  Contribute to process improvement, analyzing information, strategic planning, informing others, and emphasizing excellence.
• Strong computer and mathematical skills are necessary.  Performs a variety of tasks.  Leads and directs the work of others. 
• Must be able to walk, sit and/or stand throughout an 8-hour day.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Work environment sometimes requires special safety precautions, which may require use of personal protective equipment.