Quality Assurance Specialist

Kelly Science, Engineering, Technology & Telecom

O’Fallon (MO)

On-site

USD 48,000 - 50,000

Full time

2 days ago
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Job summary

Kelly Sciences is seeking a Quality Assurance Specialist for a premier medical device organization in O'Fallon, MO. The role focuses on quality system activities, CAPA, audits, and documentation to ensure regulatory compliance.

The position offers pay at $35–$36 per hour, depending on experience, and a contract length through June 2027 with potential extension. A Bachelor’s degree in a scientific or technical field is required, with preferred experience in regulated environments.

Qualifications

  • Bachelor’s degree in a scientific or technical field is required.
  • Experience with quality systems in a regulated environment preferred (medical device/pharma).
  • Proficient with electronic quality system software and Microsoft Office.
  • Strong attention to detail, organized, and well-documented.
  • Able to work in cross-functional teams and communicate clearly.

Responsibilities

  • Administer and document quality system activities within electronic quality system software.
  • Manage product complaint intake, evaluation records, and NCR documentation.
  • Ensure calibration documentation, controlled document changes, and quality data metrics.
  • Compile and report quality metrics including nonconformance metrics and QPIs.
  • Assist with internal and external audit support, including record retrieval and document control.
  • Prepare and manage Document Change Requests (DCRs) and CAPA documentation.
  • Ensure all quality system records are accurate, timely, traceable and compliant.

Skills

Attention to detail
Documentation skills
Cross-functional collaboration

Education

Bachelor's degree in a scientific or technical field

Tools

Quality management software
Microsoft Office

Job description

Kelly Sciences is seeking a Quality Assurance Specialist to work at a premier medical device organization in O'Fallon, MO.

Pay Rate $35–36 per hour, depending on experience

Length of assignment until June 2027 with possible extension

What’s a typical day as a Quality Assurance Specialist? You’ll be:

  • Supporting the Quality Assurance team by administering and documenting quality system activities within electronic quality system software
  • Managing product complaint intake, evaluation records, and nonconformance (NCR) documentation
  • Ensuring calibration documentation, controlled document changes, and quality data metrics are accurately maintained
  • Compiling and reporting quality metrics, including nonconformance metrics and Quality Performance Indicators (QPIs)
  • Assisting with internal and external audit support, including record retrieval and document control
  • Preparing and managing Document Change Requests (DCRs) and supporting CAPA documentation
  • Ensuring all quality system records are accurate, timely, complete, traceable, and compliant with regulatory requirements

This job might be an outstanding fit if you:

  • Have a Bachelor’s degree in a scientific or technical field (required)
  • Possess experience with quality systems in a regulated environment (preferred: medical device, pharmaceutical, or similar)
  • Are proficient with electronic quality system software and Microsoft Office Suite
  • Demonstrate strong attention to detail, organizational, and documentation skills
  • Can work effectively in a cross-functional team and communicate clearly
  • Are committed to patient safety and regulatory compliance
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