QA/QC Manager IVD / Medical Device Manufacturing

Location: Noida

Experience: 5+ Years

Qualification: B.E./B.Tech Electronics, ECE, Instrumentation, Electrical or related field

Job Summary

Experienced QA/QC Manager to lead quality operations for IVD/diagnostic medical device manufacturing, QMS,

product quality, audits, compliance, and continuous improvement.

Key Responsibilities

- Lead/manage QA/QC function, team, and processes
- ISO 13485 QMS and quality documentation
- ISO 14971, Risk Management, FMEA, and risk files
- NCR, CAPA, RCA, deviations, and complaints
- Internal, external, regulatory, and customer audits
- IQC/IPQC/FQC/BMR and inspection processes
- IQ/OQ/PQ, calibration, verification/validation
- Design transfer from R&D;, process validation, and change control
- Investigate product, electronic, process, field,



and customer issues
- Monitor quality KPIs, rejection, rework, and failure trends
- Coordinate with R&D;, Production, Engineering, and Service
- Traceability, documentation accuracy, and audit readiness
- Defect reduction and process improvement

Key Skills ISO 13485 | ISO 14971 | IVD | Medical Devices | QA/QC | QMS | CAPA | NCR | RCA | FMEA | Risk Management

IQC | IPQC | FQC | BMR | IQ/OQ/PQ | Validation | Calibration | Audit | Change Control | Quality Improvement |

Electronics Manufacturing

Preferred

Hands-on experience in IVD, diagnostic equipment, medical devices, or electronics manufacturing.

📌 QA/QC Manager (Noida)
🏢 Primary Healthtech
📍 Noida