Beschreibung
* Drive compliance for innovative healthcare products.
* Grow in a collaborative, cross-functional R&D environment.
## About Our Client ##
Our client is a global leader in the life sciences and bioprocessing industry, delivering innovative technologies. Operating in a highly regulated environment, the company is committed to quality, compliance, and continuous innovation across its product portfolio.
## Job Description ##
* Act as the primary Quality and Compliance representative for the Disposable Kits R&D team.
* Ensure Design Control and Quality Management System requirements are applied throughout product development and lifecycle activities.
* Provide compliance guidance for engineering changes, product modifications, and sustaining activities.
* Review and support Design Control documentation, including design reviews, risk management files, and change control records.
* Support the planning and execution of Verification and Validation (V&V) activities.
* Conduct or support compliance assessments related to product, process, supplier, and documentation changes.
* Lead or participate in investigations involving deviations, non-conformances, complaints, and CAPAs.
* Collaborate closely with Regulatory Affairs, Quality, Manufacturing, and R&D stakeholders.
* Promote audit readiness and support regulatory inspections when required.
* Drive continuous improvement initiatives related to Design Control, Quality, and Compliance processes.
* Provide training, coaching, and guidance to project teams on quality and regulatory expectations.
## The Successful Applicant ##
* Academic degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or a related field.
* 6 years of experience in Quality Assurance, Design Assurance, R&D Compliance, or Product Development Quality within a regulated industry.
* Strong expertise in Design Controls, Change Control, Risk Management, Verification & Validation, and Product Lifecycle Management.
* Good understanding of medical device and/or biopharmaceutical quality and regulatory requirements.
* Knowledge of regulations and norms : ISO 13485, FDA 21 CFR Part 820, and EU MDR principles.
* Experience working within Quality Management Systems supporting product development and sustaining activities.
* Familiarity with CAPAs, deviations, non-conformances, complaint investigations, and post-market quality processes.
* Experience participating in audits and regulatory inspections is highly advantageous.
* Strong analytical, problem-solving, and risk assessment capabilities.
* Ability to work independently while effectively influencing and coordinating cross-functional teams.
* Excellent communication and stakeholder management skills.
* Fluent in English; French is a strong advantage.
## What's on Offer ##
* Opportunity to contribute to innovative products that support the development of life-changing therapies.
* Dynamic and collaborative international R&D environment with broad stakeholder exposure.
* Collaborative culture and engaging cross-functional teamwork.
Quote job ref
JN-072026-7060279
Job Function
Engineering & Manufacturing
Specialisation
Quality
Industry
Healthcare / Pharmaceutical
Where
Geneva
Contract Type
Interim
Job Reference
JN-072026-7060279