Key Responsibilities: Device Measurements & Inspections:Perform routine inspections and measurements on products to ensure they meet quality specifications.Use measurement tools (e.g.,calipers, micrometers) to check dimensions and product appearance.Identify and report any discrepancies, non-conformities, or defects in the products.Documentation Control:Assist in the documentation of all quality-related records (inspection reports, test results, batch records).Ensure all documents are accurately maintained and ready for internal audits and regulatory reviews.Support the document control process by following SOPs for filing and organizing quality documentation.Support for Quality Control Procedures:Assist in implementing quality checks based on the QMS and SOPs.Ensure that all products are consistently meeting the required specifications during each production stage.Review and document inspection results and provide feedback for continuous improvement.Internal Audit Assistance:Support the preparation for internal audits in line with the ISO 13485 certification process.Assist in audit readiness, ensuring that all necessary documentation and records are in place.Identify areas for improvement and collaborate with the team to implement corrective actionsCommunication with the Team:Effectively communicate any quality issues or non-conformities identified during inspections to the production team or management.Work closely with cross-functional teams to ensure that corrective actions are taken on time and that any quality-related problems are addressed promptly.Product Knowledge & Training Support:Stay up-to-date with product specifications and quality standards.Support the training of new team members on quality procedures and standards.Collaborate with the QA/QC & Regulatory Compliance Manager to enhance quality assurance processes.

Key Responsibilities: General Office Administration:Greet and assist visitors, clients, and employees, providing a professional and friendly office environment.Answer and direct phone calls, take messages, and respond to general email inquiries.Manage office supplies, inventory, and order items as necessary to maintain office functionality.Organize and maintain the office filing system (both digital and physical), ensuring all documents are up-to-date and easily accessible.Document Management & Record Keeping:Assist in maintaining and organizing critical documents, such as quality management system (QMS) documents, SOPs, and ISO 13485 certification-related materials.Assist in the preparation and filing of various reports and records, ensuring compliance with regulatory standards.Track and organize important contracts and documents for easy retrieval.Ensure that sensitive information is handled confidentially and in compliance with company policies.Support for Meetings & Communication:Schedule and organize internal meetings, preparing agendas, taking minutes, and following up on action items as required.Coordinate and prepare materials for team meetings, regulatory audits, and internal reviews.Serve as the point of contact between employees, managers, and external clients for general office communication.Coordination of Logistics and Travel:Organize and manage travel arrangements for the management team (e.g., booking flights, accommodation, transportation).Prepare detailed travel itineraries and ensure that all travel-related documents are ready and accessible.Assist with organizing logistics for any company events, client meetings, or external visits.Support for Quality Management Systems (QMS):Assist in tracking and managing QMS-related documentation.Help prepare for internal audits and ensure that all documentation is available and organized for review.Provide administrative support to the QA/QC team as needed in preparing and maintaining records for ISO 13485 certification.Vendor & Supplier Coordination:Act as the liaison for vendors, suppliers, and service providers, ensuring timely communication and resolution of any office-related issues.Coordinate with external service providers, such as couriers, cleaning services, or office equipment maintenance.Ensure timely and accurate processing of invoices and payments for office-related services.Inventory & Office Supplies Management:Monitor the inventory of office supplies, and order necessary items to ensure seamless office operations.Maintain records of office supplies usage and ensure costs remain within budget.Ad-Hoc Administrative Tasks:Provide assistance with any other administrative tasks or projects as needed, including helping with new employee onboarding and orientation.Handle mail, packages, and deliveries promptly, ensuring they are distributed to the appropriate individuals.