Quality Manager – Medical Devices | Product Quality & Regulatory

• *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