Senior Quality Engineer

Work Flexibility: Hybrid

What you will do:

• Change ManagementProcess Enterprise Change Requests (ECRs), Enterprise Change Notices (ECNs) in windchill onePLMEnsure 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 timelinesPerform Change analyst role and review the quality of the records including global impact assessmentsIdentify improvement opportunities and execute process improvements
• Standards ManagementOwn 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 applicableReview and update Procedure as applicableUtilize power platform tools to automate processes

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)

Travel Percentage: None

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