Senior Quality Engineer

Overview

Senior Quality Engineer role at Stryker focused on change management and standards management within a quality management system for medical devices.

What you'll do

• Manage Enterprise Change Requests (ECRs) and Enterprise Change Notices (ECNs) in Windchill onePLM, ensuring product changes are assessed, planned, implemented, verified, and documented in accordance with QMS requirements.
• Facilitate change implementation board meetings and cross-functional impact assessments.
• Drive compliance with change management procedures and established timelines.
• Perform the change analyst role and review the quality of records, including global impact assessments.
• Identify improvement opportunities and execute process improvements.
• Own and maintain the standards management process, ensuring alignment of standards with regulatory requirements and business objectives.
• Coordinate stakeholder reviews and approvals for standards updates.
• Monitor compliance with established standards and identify improvement opportunities.
• Manage the standards list as applicable.
• Review and update procedures as applicable.
• Utilize Power Platform tools to automate processes.

What you'll need

• B.Tech in Engineering with 4-7 years of work experience.
• Hands-on experience in Windchill onePLM and TrackWise.
• Hands-on experience with problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA.
• Strong analytical ability.
• Hands-on experience with Quality Management Systems per ISO 13485.
• Sound knowledge of standards management and change management processes for medical devices.
• Applied understanding of GDP and ISO 13485 (must have).
• Good understanding of FDA 21 CFR Part 820 (must have).

Nice to have

• Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.
• Demonstrated ability to self-motivate and prioritize tasks in a deadline-driven environment.
• Demonstrated ability to work effectively with others across coordinated disciplines and on multi-national teams.
• Good knowledge of automation tools (Power Platform tools).

Details

• Work mode: Hybrid.
• Location: Gurugram, India.
• Travel: None.