Review, assess, and process customer complaints in accordance with established procedures and regulatory requirements.
Conduct complaint investigations to determine failure modes, root causes, and product performance concerns.
Collaborate with manufacturing, engineering, R&D, regulatory, and service teams to support complaint resolution.
Ensure complaint records are complete, accurate, and closed within established timelines.
Support adverse event and vigilance assessments where applicable.
Act as a quality representative for complaint-related projects and initiatives.
Provide guidance and training on complaint handling requirements and best practices.
Partner with Post Market Surveillance, Regulatory Affairs, and Manufacturing teams to address quality concerns and drive product improvements.
What you Need:
Required skills:
Experience- 2 years- 4 years
Experience on Quality Management (ISO 13485 or 21 CFR 820); TrackWise tool; Root Cause Analysis (RCA), CAPA, and risk management.
Understanding on Medical Device Risk Management; New Product Development (NPD) Cycle
Problem solving and decision making and 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.)
Preferred skills:
BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
At least 1+ years of experience in complaint handling or customer quality and 1 to 4 years of experience in Medical Device/Automotive/Manufacturing domain.
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