Head of Quality & QMS – Medical Devices

NEVEON Executive Committee; Monroe (LA); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality management

Leadership

Regulatory knowledge

FDA compliance

Process improvement

Analytical skills

English fluency

Cross-functional collaboration

Ausbildung

Bachelor's degree in life sciences or engineering

Tools

QMS software

MS Office

Jobbeschreibung

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.