Quality Lead

Responsible for supplier audit planning, scheduling, and conduct supplier audits.

• Responsible for vendor/ supplier quality and management issues.

• Responsible for implementation of ISO 13485 requirements

• Responsible for formulating, document, and maintain quality standards and ongoing quality objectives.

• -Analysis of raw material, In-process samples, and finished product.

• -Auditing OEM and verify the process control and quality, suggest changes if required to improve quality.

• -Responsible to escalate technical issues to the design team and Providing product feedback and customer suggestions

to the R&D and Product Management team, also tracking the continuous improvement of the products.

• -Responsible to visit critical suppliers to verify and improve quality.

• -Interacting with OEM, testing labs, external accreditation bodies.

• -Preparing Work instructions, FMEA, RCA, CAPA, PDCA cycle, etc.

• Ensure that the processes needed for the Quality Management system are documented, established, implemented and

maintained.

• Report to the top management comprising of the CEO, Directors of various disciplines and any other person(s)

appointed by the CEO for this purpose, the effectiveness of the quality management system and any need for

improvement.

• Ensure the promotion of awareness of applicable regulatory requirements, quality management system requirements

and customer requirements (where applicable) throughout the manufacturing organization.

• represent the management and participate in routine meetings with various external agencies for the audit, regulatory

and compliance requirements and will obtain regular inputs from the management for the same and provide the

feedback.