Remote Quality Engineer - Entry Level, GMP & CAPA

Virtue America; United States; Remote; USD 42,000 - 64,000; Part time

Job summary

Virtue America is seeking an Entry-Level Quality Engineer for remote, contract-based work in a regulated pharma/biotech/medical device environment. You will assist with QMS implementation, investigations, CAPA, and compliance activities to ensure product quality meets regulatory requirements.

The role emphasizes process validation, documentation review, audits, and collaboration across Manufacturing, Engineering, QA, and QC teams to uphold GMP standards.

Qualifications

• Bachelor's degree in engineering required.
• 0–2 years in Quality Engineering or related manufacturing.
• Knowledge of GMP, FDA, and ISO standards.
• Strong analytical and documentation skills.

Responsibilities

• Support quality engineering activities across manufacturing and production operations.
• Assist with non-conformance investigations, root cause analysis, and CAPA implementation.
• Participate in process validation, equipment qualification, and product quality activities.
• Review manufacturing records, inspection reports, and quality documentation.
• Support incoming, in-process, and final product inspections.
• Assist with risk assessments, FMEA, and change control activities.
• Monitor product and process quality metrics and identify improvement opportunities.
• Support internal audits, supplier audits, and regulatory inspections.
• Collaborate with Manufacturing, Engineering, Quality Assurance, and Quality Control teams.
• Ensure compliance with GMP, FDA regulations, and applicable ISO standards.

Skills

Root cause analysis

Quality documentation

Problem solving

Analytical skills

Communication

Education

Bachelor's degree in Mechanical Engineering

Job description

Virtue America is seeking an Entry-Level Quality Engineer for remote, contract-based work in a regulated pharma/biotech/medical device environment. You will assist with QMS implementation, investigations, CAPA, and compliance activities to ensure product quality meets regulatory requirements.

The role emphasizes process validation, documentation review, audits, and collaboration across Manufacturing, Engineering, QA, and QC teams to uphold GMP standards.