Quality Engineer

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%