Quality Systems Specialist II – Medical Devices

Baxter International Inc.; Cleveland (MS); On-site; USD 88,000 - 110,000; Full time

Benefits offered by this job

Medical and dental coverage from day 1

401(k) with company matching

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days

Job summary

Baxter International Inc. in Cleveland is seeking a Quality Systems professional to implement and sustain cGMP-aligned quality systems and procedures in the Devices department. You will guide cross-functional teams, train technicians, and champion continuous improvement across the plant.

The role requires a Bachelor’s degree in a relevant field, knowledge of quality systems, and FDA manufacturing experience; Six Sigma Green Belt and Lean Manufacturing are preferred. Travel may be needed.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry or Engineering.
• Good knowledge of quality systems and procedures.
• FDA manufacturing experience required.
• Six Sigma Green Belt preferred; Lean manufacturing experience preferred.

Responsibilities

• Implement and maintain quality systems and procedures in Devices.
• Interview, hire and train employees; plan and direct work; appraise performance.
• Drive continuous improvement and support equipment upgrades.
• Lead cross-functional teamwork and train technicians.
• Support process validation, capability, and control studies.
• Investigate customer complaints and perform nonconformance actions.
• Track key quality metrics and ensure product conformance.
• Communicate shift activities clearly and interface with global functions.
• Apply Lean tools and 6S; ensure compliance with cGMP and SOPs.
• Maintain plant knowledge of systems and changes per Baxter procedures.

Skills

Teamwork

Communication

Independence

Travel

Physical stamina

Overhead reach

Bend and stoop

Visual acuity

Education

Bachelor's degree (Science/Engineering)

FDA manufacturing

Six Sigma Green Belt

Lean Manufacturing

Job description

Baxter International Inc. in Cleveland is seeking a Quality Systems professional to implement and sustain cGMP-aligned quality systems and procedures in the Devices department. You will guide cross-functional teams, train technicians, and champion continuous improvement across the plant.

The role requires a Bachelor’s degree in a relevant field, knowledge of quality systems, and FDA manufacturing experience; Six Sigma Green Belt and Lean Manufacturing are preferred. Travel may be needed.