Position Summary: - We are hiring a highly dedicated QA/RA Manager who will manage all quality matters in the company and act as the Management Representative as defined in the ISO 13485, 21 CFR Part 820 (FDA cGMP), Regulation (EU) 2017/745 or any other relevant standards and regulations. Job Responsibilities: - General Ensure that the compliance with ISO 13485 and other applicable regulatory requirements or quality-related standards. Ensure that SOP's and Work Instructions relating to the department are followed and are updated when needed. Ensure that the Quality Department is always adequately staffed and trained, including internal auditors. Ensure that the company's Quality Management System is established, implemented and adequately maintained; its efficiency is continuously improved, and that the system always complies with the requirements of the relevant regulatory agencies. Ensure the promotion of awareness of regulatory requirements and customer requirements throughout the organization. Quality System Ensure that all procedures and work instructions that could affect quality are described in the Quality Management System. Ensure that all procedures and work instructions described in the Quality System are following ISO 13485, GMP, product ISO standards and other applicable regulatory requirements at all times and ensure relevant parts of the Quality System are updated accordingly. Audit Ensure that internal audits are performed on a regular basis and that all areas in the Quality System are audited. Assist in supplier audits and approval of new suppliers. Non-Conformances Ensure that Customer Complaints are correctly handled and responded to. Ensure that all Non-Conformances are reported and attended to correctly and within reasonable time limits. Ensure that corrective actions are taken in such a way that the NonConformances are solved and do not re-occur. Authorize to stop production & stop the delivery of goods to customer whenever there are any non-conforming products observed. Inspection Ensure that there is adequate inspection performed and all goods to be inspected have proper inspection criteria. Ensure that goods rejected at inspection, or lacking inspection criteria, are not transferred to the next stage. Ensure that NC is issued for every non-conformity observed during inspection. Engineering Change Order/ New Products Ensure that new/revised products cannot be sold until all necessary steps, including updating of MFG/PRO, validation, device registrations, etc, have been performed and correctly documented. Release of Products Ensure that a Certificate of Conformance is created for all sold products. Ensure that sterilized products and finished goods from sub-contractors with COC are released accordingly. Ensure that Pharmaceutical Unit's Batch Records are released accordingly. Authorized to release the finished Pharmaceutical products to customers. Management Review Ensure that Management Review is regularly performed and in accordance with applicable processes. Ensure that the Management Review agenda is established and information needed for the Management Review is available during the Management Review. Validation Ensure that validation, annual validation review and product stability study are carried out accordingly. Requirements Candidate must possess at least a college Degree in Science/Chemistry Engineering or equivalent. At least three (3) years' experience at the Managerial level in handing medical devices Quality Assurance/Quality Control tasks. Preferably with at least one year's experience working in a manufacturing environment that is ISO 13485 certified. Knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP. Have similar experience working in a clean room environment. Able to work in a team and under minimum supervision. Strong interpersonal, analytical and problem-solving skills. Proactive, resourceful, willing to learn. Good written and spoken English and Bahasa Melayu. Computer literate.
