Senior Quality Engineer - Change & Standards Management

About the role

Stryker is looking for a detail-oriented, analytical Senior Quality Engineer in Gurugram, working in a hybrid setup. The role focuses on managing product changes and maintaining quality standards for medical devices, ensuring they meet regulatory requirements and QMS rules.

Key responsibilities

• Manage Enterprise Change Requests (ECRs) and Enterprise Change Notices (ECNs) in Windchill onePLM, assessing, planning, implementing, verifying and documenting product changes in line with QMS requirements
• Facilitate change implementation board meetings and cross-functional impact assessments, and drive compliance with change procedures and timelines
• Act as a change analyst, reviewing the quality of records including global impact assessments
• Identify improvement opportunities and execute process improvements
• Own and maintain the standards management process, keeping standards aligned with regulatory requirements and business objectives
• Coordinate stakeholder reviews and approvals for standards updates, monitor compliance with standards, manage the standards list and update procedures as needed
• Use Power Platform tools to automate processes

Required profile

• B.Tech in Engineering with 4-7 years of work experience
• Applied understanding of GDP and ISO 13485 (must have)
• Good understanding of FDA 21 CFR Part 820 (must have)
• Sound knowledge of standards management and change management processes for medical devices

Required skills

• Windchill onePLM and TrackWise hands-on experience
• Problem-solving methodology, root cause analysis, 7 QC tools, problem solving and CAPA
• Quality management systems per ISO 13485
• Preferred: Power Platform automation tools, experience with multi-national teams and prioritizing in deadline-driven environments