Quality Assurance & Control (Manufacturing, Transport & Logistics)A global disrupter and award-winner in medical imaging technology, Cylite's innovative HP-OCT product range is redefining how optometrists, ophthalmologists and researchers detect and treat eye disease with its patented technology. With customers across USA, Europe and Australia, we are looking to rapidly scale our product offering and production capabilities. To support this growth, we are looking for a talented Quality Manager to lead our quality team.About the Role:Reporting to the VP Quality & Regulatory, the Quality Manager leads a specialty team in developing and implementing the Quality Management System to ensure acceptable quality standards from Engineering design through to production and testing of our final product. Working closely with the Operations team, the Quality Manager leads the Quality team to identify, investigate and advise on any quality issues related to our QMS, product design and production processes.Responsibilities include:Develop a high level of personal expertise on Cylite's product designs, construction of assemblies, and all corresponding documented processes.Perform Management Representative responsibilities and authorities of the Quality Management System (QMS) and report on QMS performance.Assess performance of the QMS and implement continuous improvement initiatives.Contribute to the overall business strategy through developing and driving the Quality Teams goals and objectives.Collaborate with NPI, Production, Engineering and Regulatory teams to define product quality benchmarks and acceptance criteria to meet QMS, Regulatory and Safety Standards, and Customer requirements.Documentation controlQuality audits and certifications (internal and external)Manage Corrective and Preventive Actions (CAPA) and Non-conforming product management (NCR)Supplier qualification, FAIR and continuous quality monitoring and managementWork with Service and Regulatory on post market surveillance, customer complaint and feedback, product recall and reportingDevelop Quality Control plans and processes aligned with Cylite's QMS.Lead the QC Team to develop QC plans and processes including manufacturing in-process and incoming goods QC inspections and tests and final product inspection and release.Review design, engineering, or process changes and update Quality process/specifications to ensure continuous product conformity.Lead continuous improvement initiatives within the manufacturing environment, with a special regard to product and process quality.Target the reduction or elimination of process variations.Develop and implement tools for monitoring QC process capabilities, analyses data generated, and report results.Promote a positive and accountable culture of Quality and continuous improvement.Lead the Quality team (QC & QA) including development, guidance and mentoring.Required Skills and experience:Degree Qualified in Engineering, Quality, or the Physical Sciences.Minimum 5+ years' experience in a quality control managerial or leadership role.Prior experience in a high-technology manufacturing environment, preferably in either a medical device or optics-related industry.Knowledge and experience with quality management systems (ISO9001/ ISO13485/ FDA QSR 21CFR820).Prior experience in setting up and implementing QC plans and acceptance criteria for new/changed product, particularly at design transfer phase, is highly regarded.Proficient computer skills in Microsoft Office and ERP Systems.Experience in continuous improvement methods, such as Kaizen, Lean, Six Sigma, 5S, etc.Excellent communication skills and attention to detail.Good interpersonal skills: can collaborate effectively with cross functional team members and give training to other production technicians.Demonstrated problem solving ability.A passion for precision and quality.If you would like to apply, please forward an up-to-date copy of your resume with a covering letter highlighting the experience you consider relevant to the role.Cylite is an Equal Opportunity Employer and embraces diversity and inclusion.
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