Astam Diagnotics
Website:
astamdiagno.com
Job details:
ASTAM DIAGNOSTICS
JOB DESCRIPTION
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
- Strong 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
• B.Sc / M.Sc / B.Pharm / M.Pharm / B.Tech / M.Tech
◦ Disciplines: Biotech, Biomedical, Life Sciences, Electronics, Mechanical, Pharmacy
• ISO 13485 Lead Auditor Certification – Preferred AUTHORITY
- Authority to stop production for quality non-compliance
- Final approval of QA documents and batch release
- KEY PERFORMANCE INDICATORS (KPIS)
- Audit compliance & closure timelines
- CAPA effectiveness
- Documentation accuracy
- Regulatory compliance status
- Customer complaints & trend analysis
SALARY
25-35K Negotiable
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