Senior Quality Engineer

Stryker; Gurugram District; On-site; INR 900,000 - 1,800,000; Full time

Job summary

Stryker Gurugram is seeking a detail-oriented Change Management professional with 4-7 years of experience in medical devices. You will drive change across processes using Windchill onePLM and TrackWise, ensuring QMS compliance and robust documentation. Collaboration with cross-functional teams and regulatory alignment are key.

Candidates should have GDP familiarity, ISO 13485 and FDA 21 CFR Part 820 knowledge, and demonstrate problem‑solving skills, CAPA, and data-driven improvements.

Qualifications

• B.Tech Engineering with 4-7 years of work experience.
• Hands on experience in Windchill onePLM and TrackWise.
• Problem-solving methodology and root cause analysis, 7 QC tools, CAPA, and strong analytical ability.
• Quality Management Systems per ISO 13485.
• Knowledge of Standards management and Change Management in medical devices.
• GDP, ISO 13485 familiarity (Must have).
• FDA 21CFR Part 820 familiarity (Must have).

Responsibilities

• Change Management: process Enterprise Change Requests (ECRs) and ECNs in Windchill onePLM.
• Ensure product changes are assessed, planned, implemented, verified, and documented per QMS.
• Facilitate change implementation board meetings and cross-functional impact assessments.
• Drive compliance with change management procedures and timelines.
• Perform Change analyst role and review quality records including global impact assessments.
• Identify improvement opportunities and execute process improvements.
• Standards Management: own and maintain the standards management process.
• Coordinate stakeholder reviews and approvals for standards updates.
• Monitor compliance with established standards and identify improvements.
• Utilize Power Platform tools to automate processes.

Skills

Problem solving

Root cause analysis

Quality systems

Analytical ability

Regulatory knowledge

GDP knowledge

FDA 21CFR Part 820 knowledge

Education

B.Tech Engineering

Tools

Windchill onePLM

TrackWise

Job description

Who we want:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
• Delivers results. A driven player who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks

What you will do:

• Change Management
  • Process Enterprise Change Requests (ECRs), Enterprise Change Notices (ECNs) in windchill onePLM
  • Ensure 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 Change analyst role and review the quality of the records including global impact assessments
  • Identify improvement opportunities and execute process improvements
• Standards Management
  • Own and maintain the standards management process.
  • Ensure 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 standards list as applicable
  • Review and update Procedure as applicable
  • Utilize power platform tools to automate processes

What you need:

Required:

• B. Tech Engineering with 4-7 years of work experience
• Hands on experience in Windchill onePLM, TrackWise.
• Hands on experience of 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 on Standards management and Change Management process of medical devices.
• Applied understanding of GDP, ISO 13485 (Must have).
• Good understanding of FDA 21CFR Part 820 (Must have)

Preferred:

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