As a Quality Engineer, you will investigate customer complaints, perform analyses on product complaints for trends, manage stakeholder expectations, and coach team members on project management practices. You will focus on ensuring timely investigations and corrective actions regarding product complaints while fostering team engagement and open communication.
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%
Top Skills
Microsoft Project
Trackwise
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