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)

Travel Percentage: None