Quality Specialist – Regulatory & CAPA Focus

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

Job summary

Brooksource currently seeks a Quality Specialist to support quality functions and compliance at a regulated site. You will manage document control, CAPA/NCR investigations, and DHR review, with a focus on audit readiness, calibration, and recordkeeping.

Ideal candidates have experience in ISO 9001/13485 and FDA quality systems, plus strong MS Office skills. On-site role offering opportunities for cross-team collaboration and continuous improvement.

Qualifications

• Associate's degree and 2 years of Quality experience in a regulated industry, or a high school diploma with 6 years in a regulated industry.
• Experience in a manufacturing environment is preferred.
• Proven Quality Specialist experience and strong understanding of Quality Management Systems.
• Experience with document control and online document repositories.
• Familiarity with 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.

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 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.

Skills

Quality Systems

Document control

Regulated industry

Customer support

CAPA investigations

DHR review

Audit support

Risk management

Education

Associate’s degree

High school diploma/GED

Tools

Propel

Windchill

SAP

Job description

Brooksource currently seeks a Quality Specialist to support quality functions and compliance at a regulated site. You will manage document control, CAPA/NCR investigations, and DHR review, with a focus on audit readiness, calibration, and recordkeeping.

Ideal candidates have experience in ISO 9001/13485 and FDA quality systems, plus strong MS Office skills. On-site role offering opportunities for cross-team collaboration and continuous improvement.