R&D Compliance SME - Disposable Kits (M/F)
fortil
ABOUT FORTIL
Fortil is an international engineering and technology consulting group built on an independent entrepreneurial model. With more than 2,500 employees across 30 offices in 14 countries, Fortil empowers talented professionals to develop their expertise through challenging industrial projects while fostering innovation, autonomy and continuous growth.
JOB DESCRIPTION
As part of the expansion of our activities in French-speaking Switzerland , we are looking for an R&D Compliance SME (M/F).
You will act as the Quality and Compliance expert within multidisciplinary R&D teams developing innovative Medical Device technologies.
Your role will ensure that product development and lifecycle activities comply with international quality and regulatory requirements.
Your responsibilities include:
Support Design Control activities.
Review Engineering Changes.
Perform Risk Management activities.
Support Verification & Validation documentation.
Ensure compliance with the Quality Management System.
Participate in CAPA, deviations and non-conformity investigations.
Support audit readiness.
Collaborate with R&D, Regulatory Affairs, Manufacturing and Quality teams.
Provide compliance guidance throughout product development.
YOUR PROFILE
Required experience
5–10 years in Design Assurance, R&D Quality or Compliance.
Medical Device experience.
Design Controls.
Risk Management.
Verification & Validation.
Change Control.
CAPA.
Quality Management Systems.
Technical skills
ISO 13485
FDA 21 CFR Part 820
EU MDR
Design Controls
Risk Management
V&V
CAPA
Product Lifecycle
Languages
Fluent English required.
French is an asset.
WHY JOIN FORTIL?
At Fortil, we provide:
Continuous career development.
Challenging international engineering projects.
An entrepreneurial culture.
Opportunities to become a shareholder.
CSR initiatives.
A collaborative and people-focused environment.
Fortil is committed to equal opportunities and welcomes applications from all qualified candidates.
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