Quality Manager

vor 2 Monaten

Steinhausen, Schweiz Wemedoo Vollzeit

Wemedoo is a leader in clinical informatics, offering a comprehensive SaaS solution and accompanying professional services for the clinical research industry.  Our SaaS solution, oomnia, integrates multiple essential functions for clinical trial management, including EDC, RTMS, ePRO/eCOA, eTMF, eConsent, and CTMS all in a single unified software. Our award-winning professional services include medical writing, data management, eTMF management, and biostatistics. We help a diverse range of clients, including CROs, sponsors, government bodies, NGOs, and academic institutions, enabling them to achieve efficient, high-quality clinical research outcomes.

Tasks

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

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

Benefits

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.

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