Quality Manager - MedTech environment (m/f/d)
Michael PageWe 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.
Quality Manager - MedTech environment (m/f/d)
Our client is an established and growing international company operating in the medical devices industry, with manufacturing activities in Switzerland. The organization is recognized for its strong quality standards, innovation, and commitment to regulatory compliance.
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
