Description

We are supporting a well-established and innovative international company
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.
Quality and Compliance Sr. Director
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 jid77dcdc1afr jit0416afr jpiy26afr