Stryker seeks a Quality Engineer to manage customer complaints and investigate product performance issues in medical devices. The role involves coordinating with cross-functional teams, conducting root cause analyses, and supporting regulatory compliance in a hybrid work environment based in Gurugram.
Responsibilities
Review, assess, and process customer complaints according to regulatory standards and internal procedures
Conduct failure mode investigations and determine root causes of product performance concerns
Collaborate with manufacturing, engineering, R&D, regulatory, and service teams on complaint resolution
Support adverse event and vigilance assessments; maintain complete and timely complaint documentation
Lead quality improvement initiatives and provide training on complaint handling best practices
Requirements
2–4 years of quality assurance experience in medical device, automotive, or manufacturing sectors
Knowledge of ISO 13485, 21 CFR 820, and complaint handling procedures
Proficiency with TrackWise software, root cause analysis, CAPA, and risk management methodologies
Familiarity with medical device risk management and new product development processes
Problem-solving, decision-making, and project management capabilities
Basic competency with business intelligence or automation tools such as Power BI or UiPath
Bachelor's degree in biomedical, mechanical, electrical engineering, or related discipline preferred
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