- 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; Current 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.