Stryker
Gurugram, Haryana, India Posted 5d ago
Stryker is seeking a Quality Engineer to review, assess, and process customer complaints in accordance with established procedures and regulatory requirements. This hybrid role partners with Post Market Surveillance, Regulatory Affairs, and Manufacturing teams.
Key Responsibilities
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
Requirements
Experience of 2 years to 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 and New Product Development (NPD) Cycle
Problem solving, decision making and project management experience
Basic knowledge of BI Tools and Automation tools (e.g. Power BI, Ui Path)
Preferred Qualifications
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
