Quality System Administrator
1 week ago
About Fresenius Medical Care
We are a world-renowned provider of products and services for individuals with renal failure, and we're seeking a highly skilled Quality Assurance Supervisor to join our team.
Main Responsibilities
- Drive Quality & Regulatory compliance across the organization, ensuring alignment with business objectives.
- Manage Field Action activities, collaborating with HQ and third-party intermediates to achieve timely closure.
- Ensure timely reporting of PMS activities, including customer complaints and field actions.
- Resolve customer and supplier inquiries related to product quality assurance, ensuring global procedure compliance.
- Maintain a robust Quality Management System, supporting ISO 13485 and ISO 9001 matrix certificate continuity.
- Conduct QMS and authority audits, overseeing CAPA management and timely actions.
- Foster collaboration with external auditors and regulatory agencies during audits and follow-ups.
- Develop and implement QA audit plans in various facilities.
- Provide quality training to employees and manage documentation systems.
- Oversee HSE-related activities within the company.
- Support the department in meeting Quality KPIs and taking necessary actions.
- Lead complex, multidisciplinary, and regional/global projects to achieve quality goals or compliance, aligned with business needs.
Key Requirements
- University degree, preferably in a scientific discipline.
- Minimum 4-5 years of experience in Quality System Management in medical device and/or pharmaceutical industries.
- Auditing experience is essential, with preferred auditor certifications.
- Knowledge of healthcare, medicine, and/or biomedical sectors, along with MDD/MDR regulations.
- Fluent English language skills.
- Proficiency in MS Office applications.
- Strong analytical and problem-solving abilities.
- Effective communication and presentation skills.
- Excellent organizational and time-management skills.
- Ability to collaborate, multitask, and prioritize tasks efficiently.
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