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 current 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

📌 Quality Engineer (Engineering / Manufacturing) (Gurugram)
🏢 Stryker
📍 Gurugram