Aurolab, a globally recognized medical device manufacturing organization, is hiring a Quality Assurance Executive – Regulatory Affairs (QA-RA) for its Madurai, Tamil Nadu facility. This is a full-time, on-site opportunity for professionals with hands-on experience in quality assurance, regulatory documentation, audits, CAPA, and complaint handling within regulated healthcare or medical device environments.
This role is ideal for candidates seeking to build or strengthen their careers in QA/RA for medical devices, working closely with Production, R&D, and Regulatory teams to ensure compliance with national and international quality standards.
🔹 Key Responsibilities – Quality Assurance Executive (RA)
As a Quality Assurance Executive – Regulatory Affairs, your responsibilities will include:
Quality Systems & Compliance
- Ensure manufacturing processes comply with applicable quality and regulatory standards
- Establish, review, and update quality plans, QA procedures, and specifications
- Maintain and update quality assurance records and controlled documentation
- Perform data analysis to support continual improvement initiatives
Complaint Handling & CAPA
- Lead or participate in root cause investigations for internal and external complaints
- Initiate, document, and implement Corrective and Preventive Actions (CAPA)
- Ensure proper documentation, tracking, and closure of complaint investigations
Quality Objectives & Cross-Functional Coordination
- Define and drive quality objectives aligned with business and regulatory goals
- Coordinate with Production and R&D teams to ensure realistic and impactful objectives
- Monitor progress, support objective owners, and maintain objective documentation
Audits & Regulatory Support
- Support internal quality audits and external regulatory audits
- Ensure availability of documents during audits
- Coordinate with the Regulatory Affairs team to meet audit requirements
- Ensure timely closure of audit observations and findings
Documentation & New Product Support
- Prepare and maintain Device Master Records (DMR) for new products
- Coordinate with R&D to prepare:
- Quality Plans
- SOPs
- Risk Analysis
- Medical Device Documentation (MDD)
- Technical Specifications
🔹 Required Qualifications & Skills
Educational Qualification
- B.Pharm / M.Pharm / B.Sc / M.Sc or equivalent (Life Sciences or Pharmacy preferred)
Experience & Skills
- Experience in Quality Assurance and/or Regulatory Affairs (medical devices preferred)
- Knowledge of QMS, CAPA, audits, complaint handling, and documentation control
- Familiarity with regulatory standards and medical device documentation
- Strong coordination, documentation, and analytical skills
🔹 Salary & Benefits
- Estimated Salary Range: ₹3.5 – ₹6.0 LPA (INR) (based on industry standards and experience)
- Full-time, on-site role at a reputed medical device organization
- Exposure to regulatory audits, new product development, and global quality systems
- Career growth in Quality Assurance & Regulatory Affairs
🔹 Job Location
📍 Madurai, Tamil Nadu, India
🕘 Work Mode: On-site
📄 Employment Type: Full-time