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Base pay range
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 driven projects. Development and update of QMS procedures and associated Work Instructions and documentation. Compliance to ISO 13485:2016 and/or Medical Device Single Audit Programme (MDSAP), FDA and other global requirements. Usage of Quality Investigational tools. Not Analysis, Ishikawa, FMEA to identify the true root cause of an event. Manage, Maintain, and Implement CAPAs (Corrective and Preventative Actions). Development of flowcharts to improve QMS process understanding. Continuously improving processes to promote more agile workflows. Participation 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. Experience in providing Quality Assurance support for New Product Development, Implementation and Launch. Training of cross functional teams in using advanced quality planning tools, such as DFMEA, PFMEA, PPAP and others. Assist in preparation of Technical Files. Experience Experience and working knowledge of Quality Assurance. Experience in Medical Device Manufacturing. Usage of Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause of an event. 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. Knowledge of IEC 60601 standards, particularly 60601-1 (Electrical Safety), 60601-1-2 (EMC) and 60601-1-6 (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. Seniority level
Associate Employment type
Full-time Job function
Engineering, Manufacturing, and Quality Assurance Industries
Medical Equipment Manufacturing
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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 driven projects. Development and update of QMS procedures and associated Work Instructions and documentation. Compliance to ISO 13485:2016 and/or Medical Device Single Audit Programme (MDSAP), FDA and other global requirements. Usage of Quality Investigational tools. Not Analysis, Ishikawa, FMEA to identify the true root cause of an event. Manage, Maintain, and Implement CAPAs (Corrective and Preventative Actions). Development of flowcharts to improve QMS process understanding. Continuously improving processes to promote more agile workflows. Participation 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. Experience in providing Quality Assurance support for New Product Development, Implementation and Launch. Training of cross functional teams in using advanced quality planning tools, such as DFMEA, PFMEA, PPAP and others. Assist in preparation of Technical Files. Experience Experience and working knowledge of Quality Assurance. Experience in Medical Device Manufacturing. Usage of Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause of an event. 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. Knowledge of IEC 60601 standards, particularly 60601-1 (Electrical Safety), 60601-1-2 (EMC) and 60601-1-6 (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. Seniority level
Associate Employment type
Full-time Job function
Engineering, Manufacturing, and Quality Assurance Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
