POSITION SUMMARY:

The (Research Use Only) Quality Engineer, reporting to the Quality Director/Manager, will help develop, implement and maintain the business program including Quality business activities, the Business Management System (BMS), including quality process and procedures, and programs to establish and ensure compliance with appropriate business practices. The Quality Engineer will also be tasked with understanding the underlying quality issues and developing successful fixes, changing practices where necessary to ensure that business standards are maintained.

RESPONSIBILITIES:

• Manage/assist with the development and implementation of quality policies and procedures
• Implement and oversee the maintenance program for Business Systems (Deviations, Non-conformance, Corrective and Preventative Actions, customer complaints, etc.)
• Assume responsibilities for for the Business Management System (Software design process, assay design process, production support, supplier support process, complaints, document control, etc.) as directed by supervisor
• Participate on project teams and/or working groups, as required
• Maintain compliance with all company business policies and procedures
• Perform other duties as assigned by supervisor

QUALIFICATIONS:

• Experience with quality assurance or experience as a quality engineer
• Minimum of two years of experience with FDA and/or ISO standards and regulations
• Attention to detail with an ability to technically create and review documentation
• Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing 
• Ability to work independently, and utilize good problem-solving skills
• Ability to multitask and work within a fast-paced dynamic team environment 

EDUCATION:

• Bachelor's degree in a scientific field or applicable experience