Quality Systems Specialist – Medical Devices

Regulatory Jobs; 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 match

Employee Stock Purchase Plan (ESPP)

Paid holidays and PTO

Job summary

Baxter is seeking a quality-focused professional in Cleveland to implement and maintain the quality systems in the Devices departments. You will lead technicians, drive continuous improvement, and ensure compliance with cGMP and FDA requirements.

The role requires a Bachelor’s in a related science/engineering field, Six Sigma Green Belt, and Lean knowledge, with travel as needed. Base salary ranges from $88,000 to $110,000 plus comprehensive benefits.

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 Certification or equivalent preferred.
• Lean Manufacturing skills and experience preferred.

Responsibilities

• Implement quality systems, processes and procedures in the Devices departments.
• Interview, hire, train employees; plan, assign, direct work; appraise performance.
• Support continuous improvement and equipment upgrades.
• Manage and support area technicians; ensure teamwork.
• Oversee training and cross training of technicians; integrate new associates.
• Support process validation, capability, and control studies.
• Investigate customer complaints and perform defect/failure analysis.
• Conduct nonconformance investigations and implement corrective actions.
• Track key quality metrics and communicate findings.
• Ensure conformity decisions and interface with plant functions globally.
• Apply Lean, problem solving, process control, and project management tools.
• Maintain plant systems knowledge and documentation.
• Evaluate changes per Baxter procedures for implementation.
• Prioritize multiple tasks and projects.
• Benchmark new technologies.

Skills

Teamwork

Communication

Independent work

Travel

Physical stamina

6S principles

Education

Bachelor’s degree in Microbiology, Biology, Chemistry or Engineering

Six Sigma Green Belt Certification

Lean Manufacturing knowledge/experience

Job description

Baxter is seeking a quality-focused professional in Cleveland to implement and maintain the quality systems in the Devices departments. You will lead technicians, drive continuous improvement, and ensure compliance with cGMP and FDA requirements.

The role requires a Bachelor’s in a related science/engineering field, Six Sigma Green Belt, and Lean knowledge, with travel as needed. Base salary ranges from $88,000 to $110,000 plus comprehensive benefits.