Work Flexibility: Hybrid
What you will do:
* 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.
Travel Percentage: 10%