Quality Engineer in Gurgaon, भारत

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