QA Compliance Specialist

Overview

We are seeking an experienced QA Compliance Specialist to support Quality System and regulatory compliance activities across the organization. This role ensures adherence to corporate, divisional, and regulatory requirements (including FDA, ISO, and other regulatory bodies).

The specialist will support external audits, internal quality processes, CAPA administration, compliance reporting, and Quality System documentation updates. This position requires strong attention to detail, experience working with quality systems, and the ability to collaborate cross-functionally.

Responsibilities

Quality System & Compliance Support

• Support external audit activities (FDA, FDB, ISO registrar audits, etc.)
• Audit various areas of the Quality System
• Support Quality System processes such as CAPA, Internal Audits, and related activities
• Ensure compliance with Corporate and Divisional quality procedures
  
  

CAPA & Audit Administration

• Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports
• Track and trend compliance activities, including CAPA and IACA metrics
• Prepare and present compliance metrics for Management Reviews
• Provide timely follow-up on open corrective actions and improvement activities
  
  

Documentation & Quality Records

• Review and update Quality System procedures as needed
• File and maintain Quality Records (audit reports, CAPAs, IACAs, etc.)
• Assist in developing and conducting Quality System training
  
  

Cross-Functional Quality Support

• Participate in cross-divisional initiatives to integrate Quality System information
• Ensure compliance with regulatory standards and quality expectations
• Support continuous improvement in Quality System processes
• Perform additional duties as assigned
  
  

Qualifications & Requirements

Education

• Bachelor’s Degree in Life Sciences, Engineering, or a closely related discipline (required)
  
  

Experience

• Minimum 3–5 years of experience supporting Quality Systems, regulatory compliance, or QA processes
• Experience with CAPA, Internal Audits, documentation control, and audit readiness
• Exposure to medical device or regulated industries preferred
• Strong understanding of quality system standards (FDA, ISO 13485, QSR, etc.)
  
  

Top 5 Must-Have Skills

• CAPA Administration & Internal Audit Support
• Experience with Quality System compliance activities
• Strong documentation and record-keeping ability
• Experience supporting external regulatory audits (FDA/ISO)
• Ability to track, trend, and report quality metrics
  
  

Soft Skills

• Strong communication and coordination skills
• Highly detail-oriented and process-driven
• Ability to work independently and manage multiple priorities
• Strong analytical and documentation skills