QA/QC Manager
Primary Healthtech · Noida · onsite · Posted 18d ago
About a minute. You'll make an account on the way through.
About this role
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.
Sourced from naukri
Skills
About Primary Healthtech
Primary Healthtech
51-200
employees
2018
8 years old
Guwahati, Assam
India
₹4.9L PA avg
Avg at Primary Healthtech
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