Quality Engineer

Location: Gurugram, India

Time Type: Full time

Job Description

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%