Director of Quality Management

NEVEON Executive Committee; Monroe (NC); In loco; USD 140.000 - 180.000; Tempo pieno

Descrizione del lavoro

Greiner Bio-One in Monroe, NC seeks a Director of Quality Management to lead quality teams, ensure regulatory compliance, and drive site QMS on site in a permanent role.

The role requires 10+ years in QM, FDA/ISO/cGMP knowledge, and strong leadership, with a focus on improving product quality and customer satisfaction in a global medical device environment.

Competenze

• Bachelor's degree in life-science or engineering or related field.
• 10+ years of QM experience.
• FDA and ISO/cGMP knowledge.
• Experience in international medical device industry.
• Understanding of QM processes and tools.
• Managerial and leadership capability.
• Ability to take initiative without supervision.
• Experience with in-vitro diagnostic medical devices is advantageous.
• Excellent computer skills.
• Excellent analytical and problem-solving skills.
• Fluent in English.

Mansioni

• 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 subsystems.
• Drive local quality subsystems and contribute to global QMS harmonization.
• Liaise with other departments to ensure quality standards are met.
• Develop corrective and preventive actions where necessary.
• Monitor and review product quality.
• Quality Management Representative and overall QM compliance.
• Improve customer satisfaction and oversee operations and facility.

Conoscenze

Fluent English

Analytical thinking

Problem solving

Computer skills

Leadership

Formazione

Bachelor's degree in life-science or engineering

Descrizione del lavoro

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We are not offering you a job, but rather we are offering you a workplace that feels like home at Greiner Bio-One.

Director of Quality Management

Location: Monroe, US, 28110

Employment Type: Permanent

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
• 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

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 identifying characteristics such as gender, age, background, social status, veteran status, sexual orientation, religion, or mental and physical abilities. We have additionally set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.

Job ID: 4568

For visionaries with drive and ideas, for team players who share their knowledge and entertain new ways of thinking, forpeoplewhostrive for excellence. Our door is always open to achievers, doers and hidden talents who want to make a difference.