Overview
Quality Engineer Jobs in Elmwood Park, IL at Aegis Manufacturing & Engineering
Preferred Qualifications:
Bachelor’s degree in Life Sciences or related field
Minimum 1 year of experience in the pharmaceutical, biotech, or medical device industry
Hands-on experience working in a GMP-regulated environment
Experience reviewing documentation in a Quality or Compliance role
Familiarity with technical documentation for product design (a plus)
Strong attention to detail, fast learner, and energetic team player
Primary Objective:
The Associate Quality Systems Specialist will support the Quality team to ensure site compliance with internal and external regulations and standards, including ISO 13485, MDSAP, IVDR, and 21 CFR. This position involves documentation review, support for quality system activities, and contributing to cross-functional teams to uphold product and process quality standards.
Key Responsibilities:
Ensure documentation complies with regulatory standards and internal quality procedures
Review and audit Device History Files (DHFs), technical files, protocols, validation/stability reports, and risk management documents
Review supporting documentation for good documentation practices and regulatory readiness
Upload finalized documents into electronic document management systems (eDMS)
Collaborate with cross-functional teams to address and resolve quality issues
Review and electronically approve quality documentation and records
Support internal and external audits as needed
Assist in writing, revising, or reviewing SOPs and procedures
Meet productivity and quality standards while maintaining accuracy and compliance
Maintain training compliance and participate in continuous improvement initiatives
Weekend or extended hours may be required
Work Environment & Reporting:
Entry-level position with growth opportunity
Reports to Manager or Project Manager based on assignment
Works under supervision with day-to-day guidance from lead personnel
Job Type: Contract
Pay: $24.00 – $27.00 per hour
Expected hours: 40 per week
Schedule:
8 hour shift
Day shift
Monday to Friday
Shift availability:
Day Shift (Required)
Work Location: On the road
Show more
Title: Quality Engineer
Company: Aegis Manufacturing & Engineering
Location: Elmwood Park, IL
