Job Summary
Job Description
1. Analyze/evaluate/lead product design and continuously seek to improve product performance opportunities;
2. Coordinate with US quality/R&D team to lead continues improvement project for product on process quality, and compliance to related regulations.
3. Work with suppliers to set up and optimize the production/quality process and monitor the process control is well maintained;
4 Process quality monitoring and data analysis.
5. Supplier audit and assessment, escalate the critical finding, work out action plan for supplier process& production control improvement, follow through to ensure actions are implemented and sustained;
6. Work with vendor to identify and resolve root cause of quality issue, and lead recall investigation.
7 Executes CAPA & SCAR management, ensure the effectiveness and timely closure;
8. Supporting division QA on design control file and design transfer review, ensure product are being manufactured per Medline and regulation requirements;
9. Organize knowledge share (quality or manufacturing) with team member to assist team development
10. Validation documents review and conduct onsite validation to ensure compliance and process/product consistency.
11. Support other divisions or other assignment with professional knowledge in quality/manufacturing
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Skills Required
- Lead product/process quality improvement and performance evaluation
- Coordinate with US quality/R&D on continuous improvement projects and regulatory compliance
- Supplier audit, assessment, and implementation of corrective action plans
- Work with vendors to identify root cause and lead recall investigations
- Execute CAPA and SCAR management and ensure timely, effective closure
- Support design control file and design transfer reviews for regulatory and manufacturing compliance
- Review validation documents and conduct onsite validations to ensure process/product consistency
- Process quality monitoring and data analysis
What We Do
All across America and the world, we help healthcare systems improve patient outcomes and reduce costs through clinical and financial solutions. As both a manufacturer and distributor of medical devices and supplies, we’re made up of problem solvers. Risk-takers. Big thinkers and doers.
