Overview
Quality Assurance Coordinator – Complaint Handling& CAPA Jobs in United States at Taylor Hodson Staffing
Title: Quality Assurance Coordinator – Complaint Handling& CAPA
Company: Taylor Hodson Staffing
Location: United States
Quality Assurance Coordinator | Complaint Handling & CAPA
Location: Fully Remote (U.S.) –
About the Opportunity
Our client is seeking a Quality Assurance Coordinator to support Complaint Handling, CAPA activities, Quality Systems administration, and Post-Market Surveillance within a regulated medical device and life sciences environment. This role will work closely with Quality and Regulatory teams to maintain quality records, support complaint investigations, track CAPAs and nonconformances, and help ensure compliance with ISO 13485, FDA Quality System requirements, and internal quality procedures.
This is an excellent opportunity for an early-career Quality professional looking to gain hands-on experience across Quality Assurance, Complaint Handling, CAPA management, Quality Systems, Document Control, and Post-Market Surveillance while working alongside experienced Quality and Regulatory leaders.
The ideal candidate will have 1–2 years of experience in Quality Assurance, Complaint Handling, Quality Systems, Document Control, CAPA support, or related quality functions within a medical device, diagnostics, biotech, pharmaceutical, or other regulated environment. Experience working within an electronic Quality Management System (eQMS) such as Veeva, MasterControl, Agile, SAP, or TrackWise is highly desirable.
Key Responsibilities
Complaint Handling & Investigation Support
- Support the complaint handling process from intake through closure.
- Review, document, and maintain accurate complaint records within the quality management system.
- Coordinate with internal stakeholders to gather information required for complaint investigations.
- Follow up with cross-functional teams to ensure timely completion of complaint-related activities.
- Assist with complaint tracking, metrics reporting, and backlog reduction efforts.
- Escalate potential quality or regulatory concerns to senior Quality personnel.
- Maintain organized, audit-ready complaint documentation and supporting records.
Quality Systems & CAPA Support
- Assist with CAPA and nonconformance documentation, tracking, and follow-up activities.
- Maintain quality records and ensure documentation is complete, accurate, and audit-ready.
- Support document control and quality system processes as needed.
- Assist with retrieval of records and documentation for audits and inspections.
- Support quality metrics reporting and continuous improvement initiatives.
- Help ensure traceability between complaints, nonconformances, and CAPA activities.
Post-Market Surveillance Support
- Assist with compiling and organizing complaint and quality data for trending and analysis.
- Support periodic reviews of complaint and post-market information.
- Help prepare reports and summaries under the guidance of senior Quality staff.
- Contribute to data collection and reporting activities that support post-market surveillance programs.
Qualifications
- 1–2 years of experience in Quality Assurance, Quality Systems, Complaint Handling, Document Control, Manufacturing Quality, CAPA administration, or a related regulated environment.
- Experience within medical device, diagnostics, biotech, pharmaceutical, or other regulated industries preferred.
- Exposure to complaint handling, CAPA processes, nonconformance management, quality records, or document control activities.
- Strong attention to detail and ability to manage a high volume of documentation and records accurately.
- Excellent written and verbal communication skills.
- Ability to work independently while collaborating effectively with cross-functional teams in a remote environment.
- Proficiency with Microsoft Office or Google Workspace.
Preferred Qualifications
- Experience supporting complaint handling, CAPA, quality systems, post-market surveillance, or audit activities.
- Familiarity with ISO 13485, FDA Quality System requirements, MDSAP, EU MDR, or similar quality frameworks.
- Experience working within an electronic Quality Management System (eQMS) such as Veeva, MasterControl, Agile, SAP, TrackWise, Dot Compliance, or similar platforms.
- Basic understanding of risk management principles and regulated quality environments.
- Associate’s or Bachelor’s degree in a scientific, engineering, quality, or related discipline.
Why Join This Opportunity?
- Fully remote position with a collaborative and supportive team.
- Gain hands-on experience across Complaint Handling, CAPA management, Quality Systems, Document Control, and Post-Market Surveillance.
- Work alongside experienced Quality and Regulatory professionals.
- Build expertise within a highly regulated medical device and life sciences environment.
- Strong opportunity for career growth within Quality Assurance, Quality Systems, Regulatory Affairs, and Compliance.
