Quality Assurance Engineer

Job Title: Quality Assurance Engineer

Location: Remote

Employment Type: Contract (W2 Only)

Industry: Pharmaceutical / Medical Devices / Biotechnology

Job Summary

We are seeking a motivated Entry-Level Quality Assurance Engineer to support quality systems, compliance activities, and documentation management within a regulated pharmaceutical or medical device environment.

The ideal candidate will assist with quality processes, audit readiness, CAPA activities, and regulatory compliance while working closely with cross-functional teams.

Key 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

Required Qualifications

• 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
• GMP/cGMP
• Quality Systems
• Documentation Practices
• Strong communication, analytical, and organizational skills
• Ability to work in a team-oriented environment

Preferred Skills

• 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

Experience Required

• Entry Level / 0–2 years of relevant Quality Assurance or regulated industry experience