Quality Assurance Manager
vor 4 Wochen
At Integra LifeSciences Switzerland SAS, we're committed to creating a better future for healthcare. As a Quality System Supervisor, you'll play a vital role in shaping our quality management processes and ensuring compliance with regulatory requirements.
Key Responsibilities:- Quality Management: Implement and maintain a robust quality system that meets international standards, including ISO 13485 and 93/42 EEC.
- Audit and Compliance: Ensure internal and external audit plans are executed, and employees are trained on quality policies and regulations.
- Regulatory Compliance: Provide documentation required for international registrations in a timely and compliant manner.
- CAPA and Quality Plan: Manage CAPA and Quality Plan processes in compliance with internal procedures and applicable standards.
- KPI and Quality Reviews: Handle KPI and Quality Reviews in accordance with applicable procedures and standards.
- Training and Management: Organize necessary resources to support QS activities, ensure training processes are in place, and provide input to continuously improve the training process.
- Education: Master's degree in Engineering, Life Science, Pharmaceutical, or a related technical discipline.
- Experience: Minimum 5 years of professional work experience in quality assurance or compliance, with prior experience as a PRRC, Management Rep. delegate, or in team management.
- Skills: Fluent in French and English, strong communication, organizational, negotiation, and interpersonal skills, analytical problem-solving skills, and experience in EtQ and Trackwise software.
- Knowledge: Strong knowledge of medical device standards and regulations, including ISO 13485, 93/42 EEC, EUMDR 2017/745, 21 CFR part 820, Canadian, Japanese, Australian, and Brazilian regulations.
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