We are looking for a Quality Manager to oversee and develop a harmonized Quality Management System across two production sites in a regulated MedTech environment. This role combines operational leadership, regulatory compliance, and strategic quality oversight with direct team management responsibilities.
Description
* Act as Quality Management Representative for a certified and harmonized QMS across multiple sites
* Lead and manage QA teams across two production locations, including resource planning and development
* Ensure compliance with international regulations and standards (e.g., ISO 13485, FDA requirements)
* Oversee key quality processes such as CAPA, complaints handling, change control, and audit management
* Plan, lead, and follow up on internal, external, and regulatory audits
* Serve as the main point of contact for quality-related topics towards customers, authorities, and partners
* Monitor QMS performance and report on key quality indicators to senior management
* Drive continuous improvement initiatives across the organization
* Collaborate on regulatory topics and support cross-functional projects
Profile
* Technical background with further education in Quality Management
* Minimum 3 years experience in Quality Assurance within a regulated MedTech manufacturing environment
* Previous experience managing teams
* Good understanding of regulatory frameworks and quality standards
* Experience or exposure to Regulatory Affairs is an asset
* Strong interest in technical topics and continuous improvement (Lean mindset is a plus)
* Effective communication skills, with the ability to interact with multiple stakeholders
* Familiarity with MS Office and quality/ERP systems
* Fluent in French and/or German, with a good command of English
Job Offer
* A key leadership role within a high-quality, regulated environment
* Exposure to both operational and strategic challenges across multiple sites
* The opportunity to influence quality strategy and continuous improvement initiatives
* A collaborative and international work environment
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