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 actionsEnsures 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 MDRExperience on Quality Management (ISO 13485 or 21 CFR 820)Understanding on Medical Device Risk ManagementUnderstanding of Medical Device Design Controls & Change ControlsUnderstanding of New Product Development (NPD) CycleExperience with TrackWise and Microsoft ProjectAbility 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 institutes4-7 years of experience in Medical Device domainAt least 2+ years of experience in complaint handling or customer quality.

Travel Percentage: 10%