Quality Engineer

What you will do:

• Investigates & document customer complaints according to applicable regulatory requirements and products.
• Complete 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.
• Work closely with stakeholders & team individuals and provides, direction & coaching to drive team engagement.
• Collect inputs from all stakeholders & team members and use 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.