Quality Engineer

Work Flexibility: Hybrid

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.
• Manage stakeholder s expectations and communicate with team for the successful completion of the project. Review project progress on periodic basis with stakeholders and ensure regular feedbacks, inputs for teams development and growth.
• 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.
• Develop an open culture to instill confidence, diversity of perspectives and knowledge sharing.

What you Need:

• Experience on Post Market Surveillance as per US FDA & EU MDR
• Experience on Quality Management (ISO 13485 or 21 CFR 820)
• Understanding on Medical Device Risk Management
• Understanding of Medical Device Design Controls & Change Controls
• Understanding of New Product Development (NPD) Cycle
• Experience with TrackWise and Microsoft Project
• Ability to influence, motivate and lead the cross functional team.
• Ability to coach team members and develop them in role.
• Project management experience and experience to lead & achieve global process improvement efforts.
• Experience of working with multiple teams and collaborating across geographically spread multi-functional teams.
• TrackWise complaint handling tool or equivalent

Education

• BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
• 4-7 years of experience in Medical Device domain
• At least 2+ years of experience in complaint handling or customer quality.

Travel Percentage: 10%