QA Investigator: Medical Device Complaints & Lab Compliance

Spectraforce Technologies, Inc.; North Chicago (IL); On-site; USD 34,000 - 44,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Quality Assurance (QA) Specialist I to support product complaint documentation, investigations, and data summarization in North Chicago, IL.

This 6-month assignment focuses on determining testing steps and ensuring compliant documentation within GMP/GLP frameworks. The ideal candidate has a science/tech background, lab experience, strong communication, and the ability to manage multiple tasks with Agile practices to support QA lab processes and

Qualifications

• Bachelor's degree in science or technology.
• Lab experience; device background preferred.
• Strong written and verbal communication skills.
• Agile; ability to manage time and multitask.

Responsibilities

• Perform product complaint documentation, investigation, and review of all non-medical complaint content.
• Analyze and test routine to medium complexity products, and evaluate results.
• Ensure complaint documentation meets GMP and GLP and regulatory requirements.
• Initiate exception documents and support the investigation process.
• Support redline changes to local documents and broader team objectives.
• Budget time with minimal supervision and propose process improvements.
• Maintain a safe work environment and compliance with GxP requirements.
• Maintain training certificates as needed for assigned tasks.
• Interpret data results for conformance with expected outcomes.

Skills

Agile

Communication

Time management

Critical thinking

Interpersonal skills

Education

Bachelor's degree in science or technology

Job description

Spectraforce Technologies, Inc. is seeking a Quality Assurance (QA) Specialist I to support product complaint documentation, investigations, and data summarization in North Chicago, IL.

This 6-month assignment focuses on determining testing steps and ensuring compliant documentation within GMP/GLP frameworks. The ideal candidate has a science/tech background, lab experience, strong communication, and the ability to manage multiple tasks with Agile practices to support QA lab processes and