Quality Assurance (QA) Specialist IVD & Medical Devices
JOB PURPOSE To lead and manage the Quality Assurance function for IVD and Medical Devices manufacturing at Astam Diagnostics, ensuring full compliance with ISO 13485, CDSCO (Indian MDR), and applicable regulatory standards, while maintaining audit readiness and product quality across the lifecycle.
KEY RESPONSIBILITIES
Establish, implement, and maintain ISO 13485-compliant QMS
Ensure compliance with CDSCO / Indian MDR 2017
Control and approve
SOPs, Work Instructions (WI), and Formats
BMR/BPR, DHR, DMR
Change control documents
Lead internal, external, customer, and regulatory audits
Handle CAPA, deviations, non-conformances, and RCA
Oversee risk management activities (ISO 14971)
Manage process, equipment, and method validation
Approve suppliers and manage supplier quality
Final authority for batch/product release
Ensure documentation compliance as per ALCOA+ principles
Conduct training and maintain training records
Support future certifications (CE / FDA) if planned
Present quality metrics in Management Review Meetings
REQUIRED SKILLS & KNOWLEDGE
Solid knowledge of
ISO 13485
CDSCO / Indian MDR
ISO 14971 (Risk Management)
Hands-on experience in:
IVD reagents/devices OR electronic medical devices
Audit handling and regulatory inspections
Excellent documentation and compliance mindset
Leadership and cross-functional coordination skills EXPERIENCE 3-5 Years EDUCATIONAL QUALIFICATION