Quality Manager

Standex International is a global industrial growth company operating through our market-leading brands in electronics, cutting-edge forming technologies, engraving, and scientific refrigeration. The Quality Manager is responsible for the leadership and oversight of the Quality Management System.

Requirements

• Bachelor of Art or Science Degree, preferred degree in Engineering, Life Sciences, or Physical Sciences
• 5 Years experience in medical device, pharmaceutical, or other regulated industry is required
• 3 Years experience in quality assurance in regulated industry; Medical Device is preferred
• 2 Years experience in management is preferred
• Knowledge of 21 CFR 820, ISO 13485, MDSAP, MDD/ EU MDR
• Experience in quality systems within medical device or pharmaceutical industry
• Experience in training, management reviews, and QS metrics
• Experience leading regulatory inspections and audits (i.e. FDA or Notified Body)
• Experience in Microsoft Office (i.e. Word, Excel, PowerPoint)
• Ability to work in a self-directed environment and team environment
• Ability to influence across functional areas and make change
• Skilled project manager and change management
• Critical thinker, detailed oriented, organized, and collaborative
• Excellent written and oral communication skills
• Strong leadership and coaching skills