QA/QC Manager

Primary Healthtech Pvt. Ltd; Sector 10; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Primary Healthtech Pvt. Ltd. is seeking an experienced QA/QC Manager IVD to lead quality operations for diagnostic medical devices in Noida. The role centers on implementing and maintaining QMS, conducting audits, and driving continuous improvement across processes.

The incumbent will oversee IQC/IPQC/FQC, design transfer, validation, CAPA/NCR, and risk management aligned with ISO 13485 and ISO 14971, ensuring traceability and regulatory compliance. 5+ years of relevant experience is desired.

Qualifications

• B.E./B.Tech in Electronics, ECE, Instrumentation, Electrical or related field.
• 5+ years experience in QA/QC leadership for IVD/diagnostic medical devices.

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

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

Education

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

Job description

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.