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Quality and Compliance Sr. Director

Schweiz Festanstellung View Job Description
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.

hinzugefügt 09/04/2026

  • Key leadership role offering strong strategic and operational exposure
  • Well-established and innovative company in the medical devices sector

Firmenprofil

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

Location: French-speaking Switzerland

Stellenbeschreibung

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

Anforderungsprofil

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

Sonstige Informationen

  • 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
Referenznummer angeben
JN-032026-6982590

Zusammenfassung

Berufsfeld
Engineering & Produktion
Näheres Berufsfeld
Qualität, Technik
Branche
Healthcare / Pharmaceutical
Ort
Schweiz
Vertragsart
Permanent
Referenznummer
JN-032026-6982590

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