Quality Engineer (Medical Device)

Job Title: Quality Engineer – Medical Device Industry

Location: Illinois, USA

Job Type: Long-Term Contract

Job Summary

We are seeking a motivated and detail-oriented Quality Engineer to support quality assurance and compliance activities within a medical device manufacturing environment in Illinois. This opportunity is ideal for recent graduates or early-career professionals looking to gain hands-on experience in a highly regulated industry. The Quality Engineer will assist with quality systems, investigations, documentation review, and process improvement initiatives to ensure compliance with FDA and ISO standards.

Key Responsibilities

• Support quality assurance activities for medical device manufacturing operations.
• Assist with non-conformance reports (NCRs), CAPA, deviations, and investigations.
• Review manufacturing and quality documentation for compliance and accuracy.
• Participate in root cause analysis and corrective/preventive action implementation.
• Support internal audits and regulatory compliance activities.
• Assist with equipment, process, and validation documentation (IQ/OQ/PQ).
• Collaborate with manufacturing, engineering, and operations teams to improve product quality and processes.
• Ensure compliance with FDA regulations, GMP, and ISO 13485 standards.
• Maintain quality records and documentation in accordance with company procedures.

Required Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Life Sciences, or related field.
• 0–2 years of experience in Quality Engineering, Quality Assurance, or manufacturing environment.
• Basic understanding of GMP, FDA regulations, and ISO 13485 standards.
• Strong communication, analytical, and documentation skills.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• Internship or co-op experience in medical device or pharmaceutical manufacturing.
• Familiarity with CAPA, deviations, and validation activities.
• Understanding of quality systems and continuous improvement methodologies.

Required Skills

• Attention to detail
• Problem-solving and analytical skills
• Documentation and reporting
• Team collaboration
• Time management
• Communication skills

Work Environment

• Onsite role in a regulated medical device manufacturing facility in Illinois.
• Opportunity to work closely with cross-functional engineering and quality teams.