Quality Specialist

Eightelevengroup; St. Louis (MO); On-site; USD 41,328 - 48,216; Full time

Job summary

Eightelevengroup in St. Louis, MO is seeking a Quality Specialist for an on-site role to support quality functions and ensure compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR.

The position coordinates document control, calibration, audits, and quality data tracking to drive continuous improvement. The role requires experience in regulated industries, strong knowledge of quality management systems, and the ability to collaborate across teams to maintain compliance

Qualifications

• Associate's degree or 6 years in a regulated industry with a high school diploma.
• Experience in a manufacturing environment preferred.
• Experience in regulated industries (FDA/ISO 13485).
• Familiarity with document control and online repositories.

Responsibilities

• Complete document control transactions and maintain accurate documentation.
• Manage customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations, including coordination of investigation documentation.
• Review DHRs and support batch record release processes.
• Manage site record retention practices in compliance with regulatory standards.
• Oversee calibration activities and maintain calibration records.
• Support site inspection activities and ensure proper recordkeeping.
• Coordinate internal and external audits, including audit preparation and follow-up.
• Support supplier quality and customer assessments.
• Track and trend site quality data to identify improvement opportunities.
• Support targeted Lean activities to enhance process efficiency.
• Assist risk management activities as appropriate.
• Support the site Management Review process with data and documentation.

Skills

Document control

Quality systems

Regulatory compliance

CAPA/NCR investigations

Audit coordination

Lean

Risk management

Customer support

Education

Associate's degree

High school diploma/GED

Tools

Propel

Windchill

SAP

MS Excel

MS PowerPoint

Job description

Quality Specialist

On-Site Role

Compensation: $30 - $35

ABOUT THE ROLE

Our client is seeking a Quality Specialist responsible for supporting the administration of quality functions at a site to ensure compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory standards. This role is integral to maintaining and improving quality systems, coordinating document control transactions, managing site record retention, calibration, and inspection activities. The Quality Specialist will also facilitate customer complaint investigations, support audit coordination, assist with supplier quality and customer assessments, participate in risk management activities, track and trend quality data, and support the site management review process. The ideal candidate will have experience in regulated industries, a strong understanding of quality management systems, and the ability to work collaboratively across teams to ensure compliance and continuous improvement.

WHAT YOU'LL DO

• Complete document control transactions and maintain accurate documentation.
• Manage customer complaint investigations and complete complaint documentation.
• Facilitate CAPA (Corrective and Preventive Action) and NCR (Nonconformance Report) investigations, including coordination of investigation documentation.
• Review Device History Records (DHRs) and support batch record release processes.
• Manage site record retention practices in compliance with regulatory standards.
• Oversee site calibration activities and maintain calibration records.
• Support site inspection activities and ensure proper recordkeeping.
• Coordinate internal and external audits, including audit preparation and follow-up.
• Support supplier quality and customer assessment activities.
• Track and trend site quality data to identify improvement opportunities.
• Support targeted Lean activities to enhance process efficiency.
• Assist in risk management activities as appropriate.
• Support the site Management Review process with relevant data and documentation.
• Complete other duties as assigned by management.

WHAT YOU BRING

• Associate's degree and 2 years of experience in Quality in a regulated industry (e.g., FDA/ISO 13485), or high school diploma/GED and 6 years of experience in a regulated industry.
• Experience working in a manufacturing environment (preferred).
• Previous Quality Specialist experience and strong understanding of Quality Management Systems.
• Experience with document control and online document repositories.
• Familiarity with applications such as Propel, Windchill, or SAP.
• Knowledge of MS Office Suite, including Excel and PowerPoint.
• Experience with customer support, including responding to customer complaints or product documentation requests.