Quality Engineer

Virtue America; United States; Remoto; USD 42.000 - 64.000; Part-time

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Root cause analysis

Quality documentation

Problem solving

Analytical skills

Communication

Formazione

Bachelor's degree in Mechanical Engineering

Descrizione del lavoro

Job Title: Quality Engineer – Entry Level

Location: Remote

Employment Type: Contract

Experience: 0–2 Years

Job Summary

We are seeking a motivated Entry-Level Quality Engineer to support quality engineering activities within a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. The ideal candidate will assist with quality system implementation, process improvement, inspections, investigations, and compliance activities to ensure products meet quality and regulatory requirements.

Key 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.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• 0–2 years of experience in Quality Engineering, Quality Assurance, or manufacturing.
• Basic understanding of quality management systems and manufacturing processes.
• Familiarity with root cause analysis, CAPA, non-conformance, and problem-solving methods.
• Knowledge of GMP, GDP, and FDA regulatory requirements.
• Strong analytical, documentation, communication, and problem-solving skills.