Quality Assurance Associate – Medical Devices (0–5 Years Experience)
We are seeking a detail-oriented and motivated Quality Assurance Associate with 0–5 years of experience to join our team in the medical devices sector. This role supports the implementation, maintenance, and continuous improvement of the Quality Management System to ensure product safety, compliance, and effectiveness in accordance with applicable regulatory standards such as ISO 13485.
Key Responsibilities
- Assist in drafting, reviewing, and maintaining quality assurance policies, procedures, and work instructions
- Support the interpretation and implementation of quality and regulatory standards (ISO 13485, applicable regulatory requirements)
- Participate in planning and conducting inspections and testing of materials and products to ensure quality standards are met
- Maintain quality records and documentation in the document management system
- Support internal audits and assist in documenting audit findings
- Assist in investigating customer complaints, deviations, and non-conformance issues
- Support data collection and analysis to identify trends and improvement opportunities within the Quality System
- Assist in implementing and monitoring Corrective and Preventive Actions (CAPA)
- Participate in quality-related training programs and ensure training records are maintained
- Collaborate with cross-functional teams to support quality initiatives
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or a related field
- 0–5 years of experience in Quality Assurance or a regulated industry (medical devices preferred)
- Basic knowledge of Quality Management Systems and ISO 13485
- Familiarity with documentation control, audits, and CAPA is an advantage
- Strong attention to detail and analytical skills
- Good written and verbal communication skills
- Willingness to learn and grow within a regulated quality environment
Job Types: Full-time, Permanent
Pay: ₹18,000.00 - ₹40,000.00 per month
Benefits:
- Health insurance
- Paid sick time
- Provident Fund
Work Location: In person
