· Lead, train and mentor quality team members.

· Overseeing incoming, and final inspection activities.

· Assigning the Daily Incoming Quality Control and Final Quality Check tasks and managing them.

· Establish and track KPIs for Quality Team members

· Represent the quality function at management reviews and strategic meetings

· Final Inspection of all products including service device along with complete documentation.

· Manage CAPA investigations, root cause analysis, and effectiveness checks.

· Monitor supplier quality performance and initiate supplier corrective actions as needed.

· Support external audits (FDA, Notified Body, customer)

· Ensure timely investigation and resolution of product complaints.

· Reviewing and analyzing complaint data, root-cause- investigations to establish corrective action plans and implication

· Contribute to the development and implementation of product test plans including Verification and Validation of products and processes

· External QC/COC

· Involve in the maintenance of product documentations (DHF)

· Participate in supplier audits along with Supply Chain

· Preparation of monthly plan for FQC to achieve the target along with Operations Team.

· Managing the NCMR and coordinating with Supply Chain and suppliers to avoid rejections.

· Review of Assembly SOP, Final Quality Inspection Report, Device Verification and Validation Plan & Report and document it.

· Identify areas for improvement in processes, products, and systems.

· Promote a culture of continuous improvement using methodologies like Six Sigma, Lean, or Kaizen.