Quality Assurance Engineer

United Consulting Hub is seeking a motivated Entry-Level Quality Assurance Engineer to support quality systems and compliance activities within a regulated pharmaceutical or medical device environment. The ideal candidate will assist with quality processes, audit readiness, CAPA activities, and regulatory compliance while collaborating with cross-functional teams.

Responsibilities:

• Support Quality Assurance and compliance activities within regulated manufacturing environments
• Assist with CAPA, deviations, non-conformance, and change control processes
• Review and maintain quality documentation, SOPs, and records
• Support internal audits and regulatory inspection readiness activities
• Collaborate with Manufacturing, Engineering, Validation, and Quality teams
• Assist with investigation and root cause analysis activities
• Ensure compliance with FDA, GMP/cGMP, and ISO standards

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Biology, Chemistry, or related field
• 0–2 years of Quality Assurance or regulated industry experience
• Basic understanding of: FDA Regulations
• Basic understanding of: GMP/cGMP
• Basic understanding of: Quality Systems
• Basic understanding of: Documentation Practices
• Strong communication, analytical, and organizational skills
• Ability to work in a team-oriented environment
• Familiarity with CAPA, deviations, and change control processes
• Exposure to pharmaceutical or medical device environments
• Knowledge of ISO 13485 or quality management systems is a plus
• Experience with documentation review and audit support activities