Beschreibung

As an Associate Director of Quality Management, you will lead a quality team focused on contract manufacturing, ensuring compliance and driving continuous improvement while collaborating with various departments to enhance supplier capabilities.

Anforderungen

• •Valid Swiss work visa or existing work authorization
• •10 years of senior experience in regulated industries
• •Strong leadership, project management, and cross-regional coordination skills
• •Bachelor’s degree in a technical field; Master’s degree a plus
• •10+ years of experience in electromechanical instrumentation manufacturing
• •Strong QMS expertise; product design, manufacturing, supply chain knowledge; ideally electromechanical
• •Deep knowledge of ISO 13485, FDA QSR, ISO 14971, and international medical device regulations
• •Strong leadership, project management, and cross-regional coordination skills
• •Ability to influence stakeholders and drive results in complex environments

Aufgaben

• •Lead and develop a dedicated Contract Manufacturing Quality team
• •Drive supplier qualification, audits, and performance management
• •Champion continuous improvement using Lean, Six Sigma, and advanced quality methodologies
• •Partner with design, manufacturing, supply chain, and procurement leaders to resolve challenges and enhance supplier capabilities
• •Represent the organization during FDA and notified body inspections
• •Report key metrics and trends to senior leadership, shaping long-term strategy