Director of Quality Management

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

Accountability (result focused)

Quality Management Representative

Ensuring compliance of QM processes and local quality tasks

Improve customer satisfaction

Overseeing the operations and facility

Ensure that products meet the quality requirements

Responsibility

• Lead, manage and develop quality teams (QC QE, Product release, Complaint investigation, QMS)
• Site Management Review and KPI reporting
• Establish local process owner for quality sub systems
• Drive local quality subsystems
• Contribute to global QMS harmonization
• Liaise with other departments to ensure quality standards are being met
• Develop corrective and preventive actions where necessary
• Monitor and review product quality

Requirements

• Minimum Bachelor's Degree in a relevant life-science or engineering field
• Proven experience in QM function (10+ years)
• In-depth knowledge of FDA and international quality standards (ISO and cGMP)
• Proven experience in international medical device industry
• Understanding of state-of-the-art QM processes and tools
• Managerial and leadership capability
• Ability to take initiative and work without close supervision
• Experience with in-vitro diagnostic medical devices of great advantage
• Excellent computer skills
• Excellent analytical and problem-solving skills
• Fluent in English

Physical Requirements

• 10% of Travel Required
• Must be able to sit, stand, walk for long periods of time

Our Offer

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants - regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.