Quality Assurance Manager

vor 3 Wochen

Steinhausen, Zug, Schweiz Wemedoo Vollzeit

At Wemedoo, we are seeking a highly skilled Quality Assurance Manager to lead our clinical research quality initiatives. The successful candidate will be responsible for developing, implementing, and maintaining our Quality Management System (QMS) in compliance with ISO 13485, ISO 9001, MDR, and GCP standards.

Key Responsibilities

Develop and implement QMS policies, procedures, and processes to ensure compliance with regulatory requirements.

Oversee the creation, updating, and management of QMS documentation, including quality manuals, procedures, and records.

Conduct internal audits and prepare for external ISO certification audits to ensure 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.

Fluency 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.

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