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)
Travel Percentage: None