On a global basis, Sysmex provides instruments, reagents and software in the in vitro diagnostics (IVD) domain. IVD is essential for diagnosing disease, determining treatment methods and monitoring treatment effects.
We have augmented our business to comprehensively cover activities ranging from research and development to manufacturing, sales and support services. We create new value through proprietary diagnostic technologies and aim to foster fulfilling and healthy societies for communities around the world.
Sysmex South Africa (SSA) seeks to employ a Quality Assurance Specialist. The incumbent will operate mainly out of the SSA office based in Randburg. This function will be primarily responsible for the integration and upkeep of the total Quality Management System including all National and Corporate policies and procedures in accordance with all relevant established international regulatory bodies in South Africa & other relevant countries.
The role will include ensuring company compliance with sound QA principles related to all medical devices, associated reagents and related accessories in South Africa including GMP, SOP’s, Distributor & Internal Audits, Training and Customer Complaints. The role is also responsible for ensuring successful implementation, and maintenance of an effective quality management system. Relevant reporting of the performance of the quality system to relevant authorities and company management forms part of this job scope.
Your responsibilitiesKey player in driving all the required ISO certification processes and provide insight & guidance throughout the entire process & ensure success.
• Key player in implementation and management of the Quality Management System (QMS) at SSA
• Coordinates & ensures Organizational readiness for all inspection activities (i.e. inspections by Regulatory Authorities / Government authorities.
• Coordinate and perform internal audit and external audit (suppliers & distributor partners)
• Arranges / co-ordinates training of all relevant SOPs for all staff
• Evaluate department processes; recommends process and product improvements (where relevant)
• Implement & monitor a system for the appropriate collation and handling of customer product complaints & relevant reporting matrices as well as closure of complaint records (i.e. Receipt, investigation, evaluation, response, closure and regular maintenance thereof)
• Maintain corrective and preventative action processes (CAPA)
• Ensure good document retention practice across the organization relating to quality
• Ensures compliance with cGxP (i.e. GMp, GWP & GDP) and corresponding Guidelines where applicable
• Assure that quality related issues associated with instruments & related accessories distributed conform to cGxP requirements, Company Corporate and Company Quality standards
• Ensures implementation of quality metrics at all relevant departments, including adherence to set targets
• Coordinate Quality Management Review process for the affiliate and elevate any significant events or identified risks to management
• Co-ordinate and manage the Quality Audit Program for suppliers / distributors
• Work with process owners of CAPAs and internal audit findings and ensure appropriate corrective actions plans are implemented and verified for effectiveness.
• Provide oversight to the on-going maintenance of the Quality System procedures; ensure that changes to the procedures are consistent with the intended purpose of the Quality System
• Assessing the effectiveness of the QMS through regular trending analysis of metrics, internal audits, corrective and preventive actions, customer feedback, and other activities as appropriate
• Ensures that company and quality systems are compliant with all local guidelines and Sysmex/ SEG specific regulations as they apply to medical instruments commercialization
• Supervise Quality agreements with our existing suppliers and potential new ones.
• Handles the instrument / product safety alerts / recall SOP development and coordinates recalls
• Participate in & guide the Quality System Audits by internal / external auditors
• Maintain medical device & other relevant operations licenses for the assigned country.
Your profileEducation:
• A tertiary qualification in a scientific or healthcare field & / or quality related studies (e.g. Total Quality Management).
• Additional certification in ISO 13485 would be an added advantage
Experience: .
• At least 3 years’ medical devices / pharmaceutical industry expertise and knowledge thereof,
• A minimum of 3 years’ experience in Quality Assuarance roles ideally within the Medical Devices OR IVD industry.
• Experience with QMS systems ISO 9001 and/or ISO 13485 is essential.
• Management of product related customer complaints (including logging, communication – internal and external, follow-up on investigation and closure)
• Has experience in South Africa and Sub-Saharan Africa healthcare indusrtry, particularly in Quality Assurance.
• Management and understanding of vigilance and reporting to different African regulatory authorities.
• Self-driven with a high degree of initiative and sense of urgency.
• Ability to plan & lead projects & also work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a dynamic hands-on environment.
• Inter-dependent partnering skills, team-orientation and demonstrated ability to influence outcomes.
• Solid decision making skills.
• Excellent communications skills (verbal, written, listening, conveying messages).
• Ability to collaborate and work with multiple stakeholders within a global organization across the regions, as well as external stakeholders.
• Demonstrated ability to synthesize information to develop recommendations, and ability to persuade / influence across different levels.
• Excels at interacting with a diverse group of people across all levels of the organization
Applicants who possess outstanding knowledge of the relevant markets and healthcare industry: Medical Devices, Diagnostics and General healthcare sectors can send their CV’s to ********** before 30 April 2021.
