Job Title: Quality & Reliability Engineer (f/m/d)At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.Job OverviewReporting to the Quality Manager/Quality Supervisor, the Quality Engineer is a member of the Quality group. The successful candidate will be responsible for Quality within their prescribed area of functional responsibility. They will be working as part of a team to maintain high quality/performance standards on all TE Connectivity products. This challenging position will require an ability to work within a collaborative environment, pursuing continuous improvement and ensuring compliance to the TE Connectivity Quality System. The focus of the role is to supply high-quality medical devices and components to deliver an Extraordinary Customer Experience.ResponsibilitiesWorking cross functionally with other departments to promote the achievement of the health and safety goalsTo deliver on all KPIs that help the business achieve its goal.Perform an active role in further development and continuous improvement of the Quality Management system.Establish and maintain risk management principles and methods throughout the product realization process in compliance with the company’s Quality Management system and applicable regulations.Maintain relevant documentation to comply with quality standards and customer requirements.Offer quality guidance to the entire team in support of the day-to-day deliverables.Develop strong links with customer organizations and other project stakeholders.Support and initiate projects to ensure continuous improvement.Quality review of responsible area validation documentation.Investigate root causes and implement effective corrective actions to prevent re-occurrence of compliance issues.Overall responsibility for production GMP standards and compliance.Establish inspection standards, sampling plans and test methods where applicable.Prepare and update procedures and associated documentation.Support customer audits and surveillance/accreditation audits.Conduct and drive audits ensuring compliance with ISO13485.Perform an active role in quality planning and new product introduction from a quality perspective.QualificationsLevel 8 degree in Quality or Degree in Science / Engineering / Quality field.Minimum of 2 years of industry experience is required.Key RequirementsWorking knowledge of FDA/ISO/MDD Quality systems for Medical Device companies.Experience within a similar role as Quality Engineer is an advantage.Quality experience in component and device manufacturing desirable.Excellent written and oral communication skills essential.
#J-18808-Ljbffr