Quality Manager(m/w/x)

Beschreibung

As the senior quality leader, you will safeguard medical device integrity by overseeing the QMS and leading a dedicated team to uphold world-class standards and regulatory compliance.

Anforderungen

• •Bachelor's degree or equivalent
• •10+ years of Quality Management experience
• •Strong medical device regulatory knowledge
• •Strong English and German skills
• •Understanding of safety and protection standards
• •Excellent communication and leadership skills
• •Reliability, integrity, accuracy, and judgment
• •Strong interpersonal and organizational skills
• •Technical understanding of medical manufacturing
• •Strong analytical thinking skills
• •Proficiency with MS Office and ERP
• •External Quality Manager training
• •Six Sigma Green or Black Belt
• •Experience with validation or change management
• •Familiarity with continuous improvement frameworks

Aufgaben

• •Oversee the Quality Management System
• •Manage CAPA and Non-Conformances
• •Handle SCAR and customer complaints
• •Direct supplier and risk management
• •Supervise validation and change management
• •Maintain records and regulatory compliance
• •Ensure adherence to EN-ISO13485 standards
• •Lead incoming and in-process inspections
• •Manage final testing and inspection criteria
• •Oversee inspection methods and equipment
• •Act as Quality Management Representative
• •Coordinate internal and external audits
• •Conduct supplier and customer audits
• •Lead and develop quality team members
• •Manage performance and development planning
• •Execute business-aligned continuous improvement initiatives

Tools & Technologien

Benefits