Senior QA Engineer - Quality & Process Excellence

Medline; Virginia; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a QA-focused leader to analyze and drive product design improvements and to coordinate with US quality and R&D teams on process quality and regulatory compliance.

The role collaborates with suppliers to optimize production/quality processes, conducts validation, and leads CAPA/SCAR activities while ensuring timely closure and cross-divisional knowledge sharing.

Qualifications

• Experience in leading design/quality improvements for medical devices or regulated products.
• Strong data analysis and problem solving skills in a QA/production environment.
• Knowledge of CAPA/SCAR processes and regulatory requirements.

Responsibilities

• Analyze/evaluate/lead product design and continuously seek to improve product performance opportunities.
• Coordinate with US quality/R&D team to lead continues improvement project for product on process quality, and compliance to related regulations.
• Work with suppliers to set up and optimize the production/quality process and monitor the process control is well maintained.
• Process quality monitoring and data analysis.
• 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.
• Work with vendor to identify and resolve root cause of quality issue, and lead recall investigation.
• Executes CAPA & SCAR management, ensure the effectiveness and timely closure.
• Supporting division QA on design control file and design transfer review, ensure product are being manufactured per Medline and regulation requirements.
• Organize knowledge share (quality or manufacturing) with team member to assist team development
• Validation documents review and conduct onsite validation to ensure compliance and process/product consistency.
• Support other divisions or other assignment with professional knowledge in quality/manufacturing

Skills

Product design analysis

Quality improvement

CAPA & SCAR

Supplier management

Validation

Data analysis

Regulatory compliance

Root cause analysis

Job description

Medline Industries, LP seeks a QA-focused leader to analyze and drive product design improvements and to coordinate with US quality and R&D teams on process quality and regulatory compliance.

The role collaborates with suppliers to optimize production/quality processes, conducts validation, and leads CAPA/SCAR activities while ensuring timely closure and cross-divisional knowledge sharing.