Knowledge of ISO standard competencies

Prepare import/export documentation, including customs declarations, invoices, packing lists, certificates of origin, and permits. Ensure all information is accurate, complete, and compliant with customs regulations. Submit customs documentation via online portals (e.g., uCustoms in Malaysia). Liaise with customs officers to resolve any documentation issues or queries. Calculate and verify applicable duties, tariffs, and taxes based on product classification (HS codes). Ensure accurate payments are made to customs authorities and receipts are recorded. Monitor the status of shipments and ensure timely customs clearance. Coordinate with freight forwarders, logistics teams, and port authorities to facilitate cargo release. Maintain organized records of all customs-related transactions for audits and regulatory checks. Keep up to date with changes in customs regulations, trade agreements, and import/export laws. Communicate with clients or internal departments regarding clearance status, required documents, or compliance issues. Advise clients on import/export procedures, restrictions, or special requirements (e.g., controlled goods).

Label and packaging development and qualification (Primary, Secondary and Tertiary) for various temperature applications - Develop testing strategies and protocol documentation - Lead qualification activities for product labeling and packaging that requires temperature control throughout various supply lanes - Work with vendors to optimize packaging and labeling solutions based on client requirements - Communicate with internal stakeholders to monitor project timelines, status to ensure project deliverables are met in support of regulatory filing deadlines - Coordinate material procurement and testing oversight - Generate test reports based on resulting test data.

Prepare and process shipping documents such as bills of lading, cargo manifests, delivery orders, and gate passes. Handle vessel clearance documents required by port authorities, customs, and shipping lines. Input cargo and container information into port management or Terminal Operating Systems (TOS). Maintain accurate and up-to-date records of incoming and outgoing cargo and vessel details. Coordinate with shipping agents, freight forwarders, customs brokers, and port operations staff to ensure documentation accuracy. Follow up on missing or incomplete documentation and resolve discrepancies. Ensure all documents comply with port regulations, customs procedures, and international shipping standards. Support audits and inspections by providing relevant records and reports. Assist customers and logistics partners with document-related queries. Provide timely updates on cargo release, vessel arrival/departure status, and clearance timelines. Generate daily, weekly, or ad hoc reports on cargo movements, vessel schedules, and document processing activities.

Develop and maintain quality control systems to ensure that products meet required specifications and quality standards before they reach the customer or the market. - Implement and oversee inspection and testing procedures for raw materials, in-process materials, and finished products. - Manage the quality control laboratory operations, including equipment calibration, maintenance, and the procurement of testing supplies. - Ensure that laboratory personnel are trained and follow standard operating procedures (SOPs) for accurate and reliable test results. - Analyze quality control data to identify trends, root causes of non-conformance, and areas for improvement. - Prepare and present quality control reports to senior management and other stakeholders. - Ensure that all quality control activities comply with industry regulations and standards, such ISO, or other relevant guidelines. - Stay updated on regulatory changes and implement necessary adjustments to quality control processes. - Lead and manage the quality control team, including hiring, training, performance evaluation, and professional development. - Foster a culture of quality and continuous improvement within the team. - Work with suppliers to ensure the quality of raw materials and components, including conducting supplier audits and reviews as necessary. - Collaborate with the procurement team to establish quality requirements for suppliers. - Drive continuous improvement initiatives in quality control processes to enhance efficiency, reduce waste, and improve product quality. - Implement new technologies or methodologies to advance quality control capabilities. - Address customer quality issues and concerns promptly, ensuring customer satisfaction and maintaining the company's reputation for quality. - Collaborate with customer service and sales teams to understand customer quality expectations and feedback. - Lead the investigation of product quality issues and implement corrective and preventive actions to prevent recurrence. - Monitor the effectiveness of Corrective and Preventive Actions and ensure that improvements are sustained over time. - Work closely with the quality assurance, manufacturing, R&D, and regulatory affairs teams to ensure a cohesive approach to product quality. - Participate in product development and scale-up activities to establish quality control criteria for new products.

Liaise with all relevant departments to ascertain current compliance levels. - Provide training and education to team members regarding regulatory compliance. - Ensure that all team members are aware of the procedures to be followed to adhere to compliance requirements. - Conduct regular audits in all required areas to ascertain compliance levels. - Develop and implement compliance improvement plans where required. - Keep up to date with industry standards. - Delegate tasks to other departments to bring compliance levels up. - Make reports, where necessary, to the governing body. - Assist Regulatory Authorities with completing site visits and external audits. - Prepare for, and conduct audits alongside external authorities.

Tasked with routine maintenance of manufacturing equipment as well as helping to troubleshoot when issues arise and provision of computer programming and instrumentation support as well as designing and developing specialised instrumentation and equipment as required. Due to the regulation of the medical devices they are required to keep detailed and accurate documentation of their work.