Quality Manager (m/w/d)

October 1, 2024

Wemedoo AG

Zug

FULL TIME

Key Responsibilities: 

Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, ISO 9001, MDR, and GCP standards.
Oversee the creation, updating, and management of QMS documentation, ensuring all processes align with the latest regulatory requirements.
Drive internal audits and prepare for external ISO certification audits, ensuring the company meets all necessary compliance standards.
Implement and manage quality processes, including CAPA, risk management, and corrective actions, to ensure adherence to ISO 13485 and related standards.
Provide training and guidance to staff on ISO requirements and quality best practices, ensuring a company-wide commitment to compliance and quality.
Maintain and enhance quality data collection and reporting systems, driving continuous improvement across all functions.
Foster and maintain effective working relationships with internal teams and external regulatory bodies to support quality objectives.

Requirements: 

University degree in a scientific field, preferably in chemistry.
Extensive knowledge and hands-on experience with ISO 13485, ISO 9001, MDR, and GCP.
Several years of quality management experience, ideally within a laboratory environment.
Mandatory certification in Quality Management.
Proficiency in quality management tools and methodologies, including FMEA, 8D Report, Cause and Effect Diagram, and 5 Why Method.
Proven experience in training and mentoring staff on ISO standards and practices.
Mandatory certification as an Internal Auditor for ISO standards.
Strong attention to detail with excellent organizational skills.
Exceptional analytical and problem-solving abilities.
Fluent in both English and German

 
What We Offer: 

A dynamic and innovative work environment. 
Opportunities to work with leading-edge technology in clinical research. 
Professional development and growth within a fast-growing company. 
Competitive salary, commission structure, and benefits package.

How to Apply: 
If you are ready to join a forward-thinking team and help drive the growth of oomnia in the clinical research industry, we want to hear from you. Please share with us your CV and a motivation letter detailing your experience and why you are an excellent fit for this role. Only candidates who provide a motivation letter will be considered. 
Deadline for Applications:  31 October 2024
Job Type: 100%
Pay: CHF40’368.74 - CHF78’231.20 per year
Schedule: