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Regulatory Compliance Specialist
vor 2 Monaten
Job Summary:
We are seeking a highly skilled Product Quality Assurance Specialist to join our team at Clario. As a Product Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our medical devices with regulatory requirements.
Key Responsibilities:
- Manage technical files and provide quality management support for design controls and regulatory requirements.
- Participate in design control or study teams to provide input on necessary regulatory and quality requirements for design and study projects or changes.
- Creation and maintenance of technical files for responsible products.
- Supervision and direction of quality assurance activities of all test departments in receiving inspection, production, and process control and final inspection.
- Decision upon quality related measures before shipment of products and control execution of corrective measures.
- Participate in Internal and external Quality Projects in R&D and Production to assure fulfilment of Quality and Regulatory requirements and Clario Operating Procedures and processes.
- Organization and definition of all necessary inspections and testing techniques for the products in relationship with change management, complaint issues, final inspection and production engineering.
- Define and Implement Quality Procedures for Complaint Management, CAPA Management, Final Inspection and Change Management in agreement with supervisor.
- Perform quality checks on design control, production and study related documentation.
- Maintain and execute the change management process in accordance with standard corporate procedures.
- Compile change management, CAPA and complaint related KPIs including statistical analysis and periodic reports.
- Provide Training to departments on quality regulations and quality processes.
- Maintain customer complaint file and support other departments in processing change requests, CAPA and complaints.
- Maintain the status of documents in design projects.
- Support article introduction during development projects.
- Communicate status of Changes, CAPAs and Complaints to other departments.
- Adapt Quality Processes to changes in R&D and Production Processes if necessary.
Requirements:
- Technical education (Master/Bachelor degree or equivalent) with preferred approximately 2 years' working experience.
- Working experience in quality assurance department or design control projects preferred.
- Basic knowledge of 21CFR Part 11, 21 CFR 820, ISO 9001/13485, ICH E6 and/or other applicable regulatory standards.
- Experience managing CAPAs and complaints.
- Excellent skills in analysing issues and processes.
- Team oriented with excellent communication and organizational skills.
- MS Office applications.
- German and English fluent.
