Director of Quality Management

NEVEON Executive Committee; Monroe (LA); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Greiner Bio-One in Monroe, LA, is seeking a Director of Quality Management to lead and develop quality teams across QC, QE, and product release. The role drives site management reviews, KPI reporting, and global QMS harmonization to ensure regulatory compliance and high product quality.

Requirements include a bachelor’s in life sciences or engineering, 10+ years in QM in the medical device sector, FDA/ISO/cGMP knowledge, and strong leadership with English fluency. Travel up to 10% is expected.

Competenze

• Minimum Bachelor's Degree in life sciences or engineering.
• 10+ years in QM in medical device industry.
• Knowledge of FDA and ISO/cGMP standards.
• Experience with international medical devices.
• Strong leadership and initiative.

Mansioni

• Lead and develop quality teams (QC QE, release, investigations).
• Oversee site management review and KPI reporting.
• Establish local process owners for QM subsystems.
• Drive local QM subsystems and harmonization with global QMS.
• Ensure product quality and regulatory compliance.
• Improve customer satisfaction and oversee operations.

Conoscenze

Quality management

Leadership

Regulatory knowledge

FDA compliance

Process improvement

Analytical skills

English fluency

Cross-functional collaboration

Formazione

Bachelor's degree in life sciences or engineering

Strumenti

QMS software

MS Office

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.