The Quality Assurance Engineer supports and maintains quality systems within a regulated manufacturing environment, ensuring compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and other applicable standards.
Requirements
- Associate degree with minimum of five (5) years of experience on similar job or bachelor’s degree on science or related fields from an accredited college or university with minimum of three (3) years of experience
- Experience working in a Pharmaceutical, Medical Devices or regulated industry
- Able to read and understand technical and regulatory literature
- Knowledgeable in cGMP’s and FDA regulations
- Planning and organization skills; and ability to manage multiple projects in parallel
- Attention to detail
- Previous experience leading/managing Quality Systems such as Investigation, CAPA, Change Control, etc.
- Excellent interpersonal and communication skills
- High performance team and strong team player
- Computer proficiency: Word, Excel, and Power Point
- Able to work under pressure and meet deadlines
- Self-Starter able to work with minimal supervision
Benefits
- Medical and Dental Benefits
- Vision
- 401K with employer match
- Group Life Insurance
- Flex Spending Accounts
- Paid Time Off and Paid Holidays
- Tuition Assistance
- Corporate Discount Program
- Opportunities to Flourish Within the Company