Quality Manager

vor 3 Monaten


Zug, Schweiz Wemedoo AG Vollzeit

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: 

Deadline for Applications:  31 October 2024

**Job Type**: 100%

Pay: CHF40’368.74 - CHF78’231.20 per year

Schedule:

- Day shift
- Monday to Friday

Ausbildung:

- Diplom (Wünschenswert)

Berufserfahrung:

- Qualitätsmanagement: 5 Jahre (Erforderlich)

Sprache:

- Englisch (Erforderlich)

Lizenz/Zertifizierung:

- ISO 13485 (Erforderlich)

Work Location: In person

Application Deadline: 31/10/2024



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