Senior Quality Engineer

Work Flexibility: Hybrid

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)