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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Medicareplus International Ltd. The successful candidate will be responsible for ensuring the continued compliance of our Quality Management System with relevant Medical Device Directives, Regulations, International Standards, and Customer Requirements.
Key Responsibilities- Provide day-to-day support and maintain the effectiveness of the Quality Management System, including 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.
Please note that the duties and responsibilities within this role may change over the course of employment, which will require flexibility.
