Quality Engineer
- Company: Stryker
- Location: Gurugram, India
- Work mode: On-site
- Job type: Full-Time
- Posted: 2026-10-22
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%