Quality Assurance Manager

Work Flexibility: Hybrid

What You Will Do:

Investigates & documents customer complaints according to applicable regulatory requirements and products.
Completes complaint investigation templates.
Performs collective analyses of product complaints and reports for trends and identification of potential corrective or preventive actions.
Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
Works closely with stakeholders & team individuals and provides direction & coaching to drive team engagement.
Collects inputs from all stakeholders & team members and uses project management practices to monitor and control the progress of the project. Responsible for the timely and quality deliveries from the team.

What You Need:

Required:

Experience on Quality Management (ISO 13485 or 21 CFR 820)
Understanding on Medical Device Risk Management; New Product Development (NPD) Cycle, Experience with TrackWise tool.
Ability to influence, motivate and lead the cross functional team; to coach team members and develop them in role.
Project management experience and experience to lead & achieve global process improvement efforts.
Basic knowledge of BI Tools and Automation tools. (e.g. Power BI, Ui Path, etc.)

Education:

BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
Experience - 2yrs to 5 yrs
At least 1+ years of experience in complaint handling or customer quality and -3 years of experience in Medical Device/Automotive/Manufacturing domain.

Travel Percentage: 10%

Quality Engineer