Quality Systems Engineer

GXPeople are looking for a QMS Engineer to join a well-established Medical Device manufacturer to join their Quality team. About The Role The Quality Management System (QMS) Engineer takes full ownership of the areas of Quality Management System. The role supports the rest of the QA/RA team and wider business with issues related to overall quality assurance, control, and compliance. Key Responsibilities Support quality driven technology projects. Develop and update QMS procedures and associated Work Instructions and documentation. Ensure compliance with ISO 13485:2016 and/or Medical Device Single Audit Programme (MDSAP), FDA, and other global requirements. Utilize Quality Investigational tools. Conduct Not Analysis, Ishikawa, FMEA to identify the true root cause of an event. Manage, maintain, and implement CAPAs (Corrective and Preventative Actions). Develop flowcharts to improve QMS process understanding. Continuously improve processes to promote more agile workflows. Participate in the review and approval of processes. Conduct gap analysis for standards and regulations. Provide QMS Induction training for new starters. Contribute to product Risk Assessment. Plan and conduct internal and supplier audits, ideally as an ISO 13485:2016 Internal Auditor. Co-host Notified Body, regulatory authority, and customer audits (with QSM/SRAO). Plan and conduct Design History File and Device Master Record audits. Provide Quality Assurance support for New Product Development, Implementation, and Launch. Train cross-functional teams in using advanced quality planning tools, such as DFMEA, PFMEA, PPAP, and others. Support device testing activities (IEC standards). Assist in the preparation of Technical Files. Experience Experience and working knowledge of Quality Assurance. Experience in Medical Device Manufacturing. Utilization of Quality Investigational tools (e.g., Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA). Lead Auditor trained and certified. Working knowledge of ISO 13485:2016, MDSAP, Medical Devices Directive (93/42/EEC), and Medical Devices Regulations (EU) MDR 2017/745. Familiarity with Unique Device Identification (2013/172/EU). Knowledge of IEC 60601 standards, particularly Electrical Safety, EMC, and Usability. Experience with Risk Management to ISO 14971. If you are looking for a new start in 2025 with a well-established business that has a great reputation in the market, please apply to this advert or get in touch for more information.

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