Quality Assurance Specialist
1 day ago
Maintain the effectiveness of the Quality Management System, ensuring compliance with relevant Medical Device Directives, Regulations, International Standards, and Customer Requirements.
Responsibilities- Provide day-to-day support for Document Control, CAPA, Vigilance, Risk Management, Internal Audit, Post-Market Surveillance, Supplier Monitoring and Assessment, and Product Release activities.
- Contribute to strategic improvement projects to improve business processes in line with applicable regulatory requirements and Medicareplus Regulatory Strategy.
- Prepare and present Quality Data to analyze quality trends and support investigations, remediation, and improvement initiatives.
- Maintain current knowledge base of existing applicable and emerging regulations, standards, or guidance documents.
- Support and participate in the development of effective and efficient documented ways of working for the verification of all quality-related activities associated with the manufacture of outsourced raw materials and finished products.
- Collate and review batch records, certificates of analysis/conformance, sterilization data from subcontractors to ensure that products are made available for sale in accordance with agreed lead-times.
- Participate in the effective management of Customer Complaints, Regulatory Reporting, Non-Conformances, and CAPA.
- Prepare and analyze data for the purpose of Management Review.
- Ensure that all Change Control activities are effectively controlled, and outputs are correctly translated into documentation.
- Ensure that the Labour Standard Assurance System and the Modern-Day Slavery Act are effectively managed, and all requirements met.
- Participate in and support internal, supplier, and external audit programs.
- Write or update Standard Operating Procedures and work instructions.
- Support the RA function as directed.
- Maintain frequent contact with external sub-contract manufacturers and suppliers.
- Collate data from multiple sources, interpret, and produce meaningful quality reports with justified and balanced evidence and proposal for remediations as applicable.
- Work to tight deadlines and manage a workload which has designated lead times.
- Show initiative in problem-solving by identifying and recommending solutions to problems encountered.
- Maintain a personal knowledge of the current Quality Management System and Regulatory Requirements.
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