Head of Quality Assurance & Compliance (Medical Devices)

Greiner Bio-One Americas; Monroe (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

Greiner Bio-One Americas is seeking a Quality Management Representative to drive accountability and ensure compliance of QM processes across the site. The role focuses on improving customer satisfaction and overseeing operations to meet quality requirements.

The position requires leadership of QA/QC teams, knowledge of FDA and ISO/cGMP standards, and the ability to advance local quality subsystems while coordinating with global QMS. Fluency in English is essential.

Qualifications

• Bachelor's degree in life-science or engineering.
• 10+ years of QM experience.
• Knowledge of FDA and ISO/cGMP standards.
• Experience in international medical device industry.
• Experience with quality management processes and tools.
• Strong leadership and initiative; able to work independently.
• Experience with in-vitro diagnostic devices is advantageous.
• Excellent computer skills; strong analytical and problem-solving abilities.
• Fluent in English.

Responsibilities

• Lead and develop quality teams (QC QE, product release, complaint investigation, QMS).
• Conduct site management reviews and KPI reporting.
• Establish local process owners for quality subsystems.
• Drive local quality subsystems and harmonize with global QMS.
• Liaise with other departments to ensure quality standards.
• Develop corrective and preventive actions as needed.
• Monitor and review product quality.

Skills

Quality management

Leadership

Analytical skills

Problem-solving

English fluency

Education

Bachelor's degree

Job description

Greiner Bio-One Americas is seeking a Quality Management Representative to drive accountability and ensure compliance of QM processes across the site. The role focuses on improving customer satisfaction and overseeing operations to meet quality requirements.

The position requires leadership of QA/QC teams, knowledge of FDA and ISO/cGMP standards, and the ability to advance local quality subsystems while coordinating with global QMS. Fluency in English is essential.