Quality Manager

La Droiture; Puducherry; On-site; INR 900,000 - 1,500,000; Full time

Job summary

La Droiture in Puducherry, India, is seeking a seasoned QA leader to manage the QMS and ensure regulatory compliance across medical device manufacturing.

The role emphasizes EU MDR 2017/745, including PRRC responsibilities, overseeing incoming, in-process and final product quality. It also covers complaints, CAPA, recalls, audits, and collaboration with Regulatory Affairs to drive training and improvements.

Qualifications

• Leading QA function in the medical device manufacturing industry
• Knowledge of QMS, EU MDR, FDA, Regulatory part
• Experience in audits, CAPA and complaint handling
• Team management and leadership skills

Responsibilities

• Manage the QMS and ensure compliance
• EU MDR 2017/745 compliance (including PRRC role)
• Incoming, in-process and final product quality
• Complaints, CAPA, recalls and non-conformances
• Internal, external and Notified Body audits
• Coordinate with Regulatory Affairs
• Quality training and improvement projects

Job description

Role & responsibilities

• Manage the QMS and ensure compliance


• EU MDR 2017/745 compliance (including PRRC role)


• Incoming, in-process and final product quality


• Complaints, CAPA, recalls and non-conformances


• Internal, external and Notified Body audits


• Coordinate with Regulatory Affairs


• Quality training and improvement projects

Preferred candidate profile

• Experience in Leading QA function in the medical device manufacturing industry


• Knowledge of QMS, EU MDR, FDA, Regulatory part


• Experience in audits, CAPA and complaint handling


• Team management and leadership skills