Quality Assurance Manager

The Quality Assurance Manager is responsible for ensuring compliance with FDA regulations, VAWD policies, and client-specific requirements. They manage change control, administer quality system documents, and lead internal and external audits.

Requirements

• Bachelor of Science (B.S.) degree in Engineering, Science or related field
• Minimum of 5-7 years of experience in Quality in the medical device or pharmaceutical or other regulated industry
• A minimum of three (3) years supervisory experience
• ASQ and/or ISO Auditor Certifications
• Effective time management skills
• Impeccable verbal and written communication skills
• Ability to conduct appropriate research as needed
• Strong presentation skills
• Strong analytical skills for safety and compliance
• Attention to detail and organization
• Critical thinking
• Interest to work in a fast-paced environment
• Navigate through Quality and Warehouse Management Systems with training – MQ1, Tecsys Elite, WebCTRL
• Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
• Knowledge of applicable state and federal laws for warehousing and distribution of pharmaceutical and medical devices as well as the ability to interpret and apply rules and regulations including FDA, DEA, PDMA, DSCSA
• Intermediate public speaking and presentation skills
• Ability to track and present quality metrics/trends
• Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen)
• Must be able to travel up to 20%
• Must have a valid driver’s license