Quality and Compliance Sr. Director

We are supporting a well-established and innovative international company in the medical devices sector in the search for a Quality & Compliance sr. Director. This is a key leadership role within a highly regulated, manufacturing-driven environment, offering strong strategic and operational exposure.

Well-established and innovative international company in the medical devices sector.

Location: French-speaking Switzerland

Description

As Quality & Compliance Sr. Director, you will lead the overall Quality function on site, ensuring full compliance with global regulatory standards while driving continuous improvement across the organization.

Your responsibilities will include:

• Leading and developing the Quality function (QA, QC, manufacturing quality support, validation, and on-site regulatory activities)
• Ensuring compliance with applicable standards and regulations, including ISO 13485, ISO 9001, FDA QSR (21 CFR 820), and MDSAP
• Acting as Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745
• Overseeing and continuously improving the Quality Management System (QMS)
• Driving key quality processes such as CAPA, change control, non-conformities, and process validation
• Leading regulatory inspections and audits (FDA, Notified Bodies, internal and external audits)
• Partnering cross-functionally with Operations, R&D, Clinical, and other stakeholders
• Monitoring quality performance, identifying trends, and implementing robust corrective actions
• Promoting a strong culture of quality, compliance, and continuous improvement
• Acting as a key member of the site leadership team, contributing to strategic decision-making

Profile

Profile

• Proven experience in a senior Quality leadership role within the medical devices industry and with sterile products.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), and international regulatory frameworks
• Demonstrated experience leading regulatory inspections (FDA and Notified Bodies)
• Solid background in manufacturing environments, including process validation and quality control
• Good understanding of EU MDR and ability to take on PRRC responsibilities
• Strong leadership and stakeholder management skills
• Analytical mindset with a hands-on approach to problem-solving

Languages

• Fluent English is required
• French highly desired and/or German would be an additional asset

Job Offer

• A competitive compensation package aligned with the seniority of the role
• Relocation support for candidates moving to Switzerland
• An attractive benefits package including additional perks and advantages
• A strategic position with strong visibility and impact within an international environment
• Work from home available according to the needs of this role