Quality Engineer

Job Description – Quality EngineerA Medical Device company is seeking an experienced Quality Engineer to join our team, directly reporting to QA/RA Manager.The Quality Engineer will provide support for ensuring that products, processes, and systems meet internal quality standards and relevant regulations. The role involves cross-functional collaboration, problem-solving, driving continuous improvement, and supporting both engineering and manufacturing teams in terms of quality.Key ResponsibilitiesMaintain quality procedures, SOPs, and work instructions.Support compliance process with relevant standards such as ISO 13485, or other industry-specific regulations.Support internal and external audits.Handling nonconformities (NCRs) in production.Handling corrective and preventive actions (CAPA).Train teams on quality processes and best practices.Support suppliers' evaluation process.Support QC team as needed.Handling design changes (ECOs).Prepare quality reports, metrics, and presentations.Maintain accurate records in accordance with regulatory requirements.Provide support for other quality ongoing tasks.RequirementsBachelor’s degree in engineering, quality assurance.Minimum 3-5 years of experience in quality within the manufacturing of medical devicesExperience with ISO 13485 and/or QSR part 820.Strong analytical and problem-solving skills.Excellent organizational skills and attention to detail.Ability to work cross-functionally and manage multiple tasks.Strong communication skills; fluent English.