Job Location: Punjab
Experience: 10–15 Years
Industry: Medical Devices / Healthcare Electronics
Qualification: B.E./B.Tech – Electronics /Biomedical / Instrumentation or related field
Job Summary
We are looking for an experienced Quality Manager to lead Product Quality, Quality Assurance and QMS activities for medical electronic products such as ECG, EMG, Patient Monitoring Systems and Healthcare Electronics.
The role will focus on ensuring product safety, quality, reliability and regulatory compliance throughout the product lifecycle, from NPI and Design Transfer through production and post-market activities.
Key Responsibilities
- Lead Product Quality and Quality Assurance activities for medical devices.
- Maintain and continuously improve the ISO 13485:2016 Quality Management System.
- Ensure compliance with applicable MDR 2017, CDSCO and medical-device regulatory requirements.
- Drive quality activities during NPI, Design Transfer, prototype, pilot production, validation and product release.
- Participate in Design Reviews, Risk Management and product/process quality assessments.
- Review and ensure effective implementation of DFMEA, PFMEA, Control Plans, Process Flow and quality controls.
- Ensure appropriate Design Verification/Validation, Process Validation and Test Method Validation activities.
- Lead NCR, CAPA, deviation, root cause analysis and effectiveness verification.
- Manage Change Control/ECO from product quality and regulatory impact perspectives.
- Drive investigation of customer complaints, product failures, field failures and warranty issues.
- Support Post-Market Surveillance and complaint trending activities.
- Ensure product traceability, inspection, testing, calibration and final product release requirements are met.
- Lead and support internal, customer, supplier and certification/regulatory audits.
- Ensure timely closure and effectiveness of audit findings.
- Manage Supplier Quality and supplier corrective actions for critical components and materials.
- Monitor product quality KPIs including , rejection, complaints, field failures, CAPA and quality cost.
- Drive continuous improvement in product reliability, defect prevention and process capability.
- Work closely with R&D, Engineering, Production, Regulatory Affairs and Supply Chain teams.
- Lead, mentor and develop the Quality team.
Pay: ₹800,000.00 - ₹900,000.00 per year
Benefits:
- Health insurance
- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
