Quality Engineer

Overview

Quality Engineer role focused on customer complaint handling, investigations and quality support for medical device products.

What you'll 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'll need

• 2 to 4 years of experience.
• Experience in Quality Management (ISO 13485 or 21 CFR 820).
• Experience with TrackWise tool.
• Root Cause Analysis (RCA), CAPA and risk management experience.
• Understanding of Medical Device Risk Management.
• Understanding of the New Product Development (NPD) cycle.
• Problem solving and decision making skills.
• Project management experience and experience leading global process improvement efforts.
• Basic knowledge of BI tools and automation tools (e.g. Power BI, UiPath, etc.).

Nice to have

• 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.
• 1 to 4 years of experience in Medical Device/Automotive/Manufacturing domain.

Details

• Work mode: Hybrid.
• Location: Gurugram, India.
• Travel: 10%.