Overview Reporting to the Quality Manager, the Quality Engineer - Systems will be responsible for supporting the administration and co-ordination of all quality processes within the team in order to ensure compliance with the relevant standards. Responsibilities Plan and conduct internal audits in alignment with the appropriate standards, document findings and ensure improvement / corrective actions are implemented and effective. Support the Quality Manager with the administration of IR's, in addition to IR report generation and external auditors as required. Conduct supplier audits, document findings and ensure improvement / corrective actions are implemented and effective. Work with the Purchasing team and suppliers in order to support component issue resolution. Support with the administration and maintenance of the Quality Management System (QMS). Gather data and generate reports to support decision making within the team and wider business. Support the Quality Manager to ensure the ongoing compliance with the relevant quality, industry and regulatory standards. Identify the need for and support the implementation of continuous improvement initiatives across the business. Other duties as required. Essential Experience: Problem solving: Knowledge and experience of root cause analysis and corrective action, logical approach to resolution of issues. Data: Proven experience of collating, analysing, and presenting data. Engineering: Prior experience of working in a similar role within an engineering environment. Quality: Working in an ISO9001 or similar environment. IT Skills: Knowledge and experience of using Microsoft packages including Word, Excel, and Outlook. Desirable skills but not essential: Electronics Knowledge: Experience of working in a practical electronics environment. Auditing: Experience in conducting audits against ISO9001, processing audit documentation and improvement reports. Experience in administration and maintenance of the Quality Management System (QMS) Compliance: Acts with integrity and can work in accordance with regulation and compliance. Data Visualisation Software: Familiar with data visualisation software, such as Power BI or similar tools for date gathering and presentation. Please note: Only candidates with the relevant skills and experience will be contacted regarding this position. If you do not hear back from us within 5 days you have unfortunately been unsuccessful in your application for this position, however we may contact you in the future to discuss other opportunities. Please note: That no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job
25/04/2024
Full time
Overview Reporting to the Quality Manager, the Quality Engineer - Systems will be responsible for supporting the administration and co-ordination of all quality processes within the team in order to ensure compliance with the relevant standards. Responsibilities Plan and conduct internal audits in alignment with the appropriate standards, document findings and ensure improvement / corrective actions are implemented and effective. Support the Quality Manager with the administration of IR's, in addition to IR report generation and external auditors as required. Conduct supplier audits, document findings and ensure improvement / corrective actions are implemented and effective. Work with the Purchasing team and suppliers in order to support component issue resolution. Support with the administration and maintenance of the Quality Management System (QMS). Gather data and generate reports to support decision making within the team and wider business. Support the Quality Manager to ensure the ongoing compliance with the relevant quality, industry and regulatory standards. Identify the need for and support the implementation of continuous improvement initiatives across the business. Other duties as required. Essential Experience: Problem solving: Knowledge and experience of root cause analysis and corrective action, logical approach to resolution of issues. Data: Proven experience of collating, analysing, and presenting data. Engineering: Prior experience of working in a similar role within an engineering environment. Quality: Working in an ISO9001 or similar environment. IT Skills: Knowledge and experience of using Microsoft packages including Word, Excel, and Outlook. Desirable skills but not essential: Electronics Knowledge: Experience of working in a practical electronics environment. Auditing: Experience in conducting audits against ISO9001, processing audit documentation and improvement reports. Experience in administration and maintenance of the Quality Management System (QMS) Compliance: Acts with integrity and can work in accordance with regulation and compliance. Data Visualisation Software: Familiar with data visualisation software, such as Power BI or similar tools for date gathering and presentation. Please note: Only candidates with the relevant skills and experience will be contacted regarding this position. If you do not hear back from us within 5 days you have unfortunately been unsuccessful in your application for this position, however we may contact you in the future to discuss other opportunities. Please note: That no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job
Kirtana consulting is looking for SAP QM with EWM technical role for 6months rolling contract in London. Job description: equired Core Skills: SAP QM+EWM Functional Minimum years of experience: 10 Detailed Job Description: Primary responsibilities for the role of SAP Func SME include: -Drive or support the development of SAP QM technical concepts, supporting the business concepts and business processes with SAP solution ideas and standards. -Document the concept in Key Design Decisions or System Design Documents, align with stakeholder and present jointly with Business to the Design Authority. -Develop solution designs, functional specifications and configurations, based on requirements and user stories, shared by the business roles, mainly Product Owner. -Drive document and work package management in SAP Solution Manager, using Focused Build methodology. -Handle all CSV related needs to get formally approved system documentation. -Identify and prepare test cases, test case documentation, test data and perform unit testing and formal function testing (Screening and SAT). -Support and manage the developer to build any identified WRICEFS. -Perform required customizations (Configuration Guides). -Work in Agile Product Development Team together with PO, Scrum Master, Developer and other functional SAP experts or Business process experts. -Experiences (different per role/team). -Multi-year hands-on experience in SAP Template projects in S/4, matching the responsibilities above -Knowledge in at least 2 of the core process/functional area and related solutions. -SAP Quality Notifications, Integration with QMS Systems, for Planned and/or unplanned events. -SAP Material Inspections, incl. LIMS interface, incl. EWM integration. SAP Release & Certify
24/04/2024
Project-based
Kirtana consulting is looking for SAP QM with EWM technical role for 6months rolling contract in London. Job description: equired Core Skills: SAP QM+EWM Functional Minimum years of experience: 10 Detailed Job Description: Primary responsibilities for the role of SAP Func SME include: -Drive or support the development of SAP QM technical concepts, supporting the business concepts and business processes with SAP solution ideas and standards. -Document the concept in Key Design Decisions or System Design Documents, align with stakeholder and present jointly with Business to the Design Authority. -Develop solution designs, functional specifications and configurations, based on requirements and user stories, shared by the business roles, mainly Product Owner. -Drive document and work package management in SAP Solution Manager, using Focused Build methodology. -Handle all CSV related needs to get formally approved system documentation. -Identify and prepare test cases, test case documentation, test data and perform unit testing and formal function testing (Screening and SAT). -Support and manage the developer to build any identified WRICEFS. -Perform required customizations (Configuration Guides). -Work in Agile Product Development Team together with PO, Scrum Master, Developer and other functional SAP experts or Business process experts. -Experiences (different per role/team). -Multi-year hands-on experience in SAP Template projects in S/4, matching the responsibilities above -Knowledge in at least 2 of the core process/functional area and related solutions. -SAP Quality Notifications, Integration with QMS Systems, for Planned and/or unplanned events. -SAP Material Inspections, incl. LIMS interface, incl. EWM integration. SAP Release & Certify
Overview Reporting to the Quality Manager, the Quality Engineer - Systems will be responsible for supporting the administration and co-ordination of all quality processes within the team in order to ensure compliance with the relevant standards. Responsibilities Plan and conduct internal audits in alignment with the appropriate standards, document findings and ensure improvement / corrective actions are implemented and effective. Support the Quality Manager with the administration of IR's, in addition to IR report generation and external auditors as required. Conduct supplier audits, document findings and ensure improvement / corrective actions are implemented and effective. Work with the Purchasing team and suppliers in order to support component issue resolution. Support with the administration and maintenance of the Quality Management System (QMS). Gather data and generate reports to support decision making within the team and wider business. Support the Quality Manager to ensure the ongoing compliance with the relevant quality, industry and regulatory standards. Identify the need for and support the implementation of continuous improvement initiatives across the business. Other duties as required. Essential Experience: Problem solving: Knowledge and experience of root cause analysis and corrective action, logical approach to resolution of issues. Data: Proven experience of collating, analysing, and presenting data. Engineering: Prior experience of working in a similar role within an engineering environment. Quality: Working in an ISO9001 or similar environment. IT Skills: Knowledge and experience of using Microsoft packages including Word, Excel, and Outlook. Desirable skills but not essential: Electronics Knowledge: Experience of working in a practical electronics environment. Auditing: Experience in conducting audits against ISO9001, processing audit documentation and improvement reports. Experience in administration and maintenance of the Quality Management System (QMS) Compliance: Acts with integrity and can work in accordance with regulation and compliance. Data Visualisation Software: Familiar with data visualisation software, such as Power BI or similar tools for date gathering and presentation. Please note: Only candidates with the relevant skills and experience will be contacted regarding this position. If you do not hear back from us within 5 days you have unfortunately been unsuccessful in your application for this position, however we may contact you in the future to discuss other opportunities. Please note: That no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job
23/04/2024
Full time
Overview Reporting to the Quality Manager, the Quality Engineer - Systems will be responsible for supporting the administration and co-ordination of all quality processes within the team in order to ensure compliance with the relevant standards. Responsibilities Plan and conduct internal audits in alignment with the appropriate standards, document findings and ensure improvement / corrective actions are implemented and effective. Support the Quality Manager with the administration of IR's, in addition to IR report generation and external auditors as required. Conduct supplier audits, document findings and ensure improvement / corrective actions are implemented and effective. Work with the Purchasing team and suppliers in order to support component issue resolution. Support with the administration and maintenance of the Quality Management System (QMS). Gather data and generate reports to support decision making within the team and wider business. Support the Quality Manager to ensure the ongoing compliance with the relevant quality, industry and regulatory standards. Identify the need for and support the implementation of continuous improvement initiatives across the business. Other duties as required. Essential Experience: Problem solving: Knowledge and experience of root cause analysis and corrective action, logical approach to resolution of issues. Data: Proven experience of collating, analysing, and presenting data. Engineering: Prior experience of working in a similar role within an engineering environment. Quality: Working in an ISO9001 or similar environment. IT Skills: Knowledge and experience of using Microsoft packages including Word, Excel, and Outlook. Desirable skills but not essential: Electronics Knowledge: Experience of working in a practical electronics environment. Auditing: Experience in conducting audits against ISO9001, processing audit documentation and improvement reports. Experience in administration and maintenance of the Quality Management System (QMS) Compliance: Acts with integrity and can work in accordance with regulation and compliance. Data Visualisation Software: Familiar with data visualisation software, such as Power BI or similar tools for date gathering and presentation. Please note: Only candidates with the relevant skills and experience will be contacted regarding this position. If you do not hear back from us within 5 days you have unfortunately been unsuccessful in your application for this position, however we may contact you in the future to discuss other opportunities. Please note: That no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job
We are currently looking on behalf of one of our important clients for an IT Quality Assurance & CSV Manager (German Speaking). The role is a permanent position based in Solothurn Canton & comes with some home office allowance. Your Role: Carry out personnel, technical & people life cycle management of a IT QA & CSV team. Act as a key contact person & all-rounder in the field of IT Quality Assurance & Computer Systems Validation. Advise & support system owners, project managers or suppliers in the validation of computer systems according to internal & external GxP/GAMP specifications (eg in the field of production systems SW, SW development, MES or database systems). Independently prepare the necessary documentation & execution of tests. Support the continuous development of IT processes (eg further development of internal CSV processes or certification of IT service areas according to ISO 27001: Information Security). Act as a key contact person as a CSV expert for customers & audits. Review & approval CSV & system documentation. Your Skills: At least 5 years of relevant professional experience including experience in IT Quality Assurance, Computer Systems Validation & Computer Software Assurance. A sound knowledge of IT Security, GDPR & IT Systems & Infrastructure. Experienced with Q-Systems (eg EU: Annex 11/FDA: 21CFR Part 11). Ideally experienced in the Medical Technology Sector. A knowledge of important IT Standards & Methods (eg ISO27001, ISO 80002-2, ITIL) or ISO 13485:2016 QMS for Medical Devices. Your Profile: Completed relevant Scientific or Technical University Degree. Strong communication skills, assertive & highly quality-oriented. Fluent English & good German language skills (to at least B2 Level) are a mandatory requirement.
19/04/2024
Full time
We are currently looking on behalf of one of our important clients for an IT Quality Assurance & CSV Manager (German Speaking). The role is a permanent position based in Solothurn Canton & comes with some home office allowance. Your Role: Carry out personnel, technical & people life cycle management of a IT QA & CSV team. Act as a key contact person & all-rounder in the field of IT Quality Assurance & Computer Systems Validation. Advise & support system owners, project managers or suppliers in the validation of computer systems according to internal & external GxP/GAMP specifications (eg in the field of production systems SW, SW development, MES or database systems). Independently prepare the necessary documentation & execution of tests. Support the continuous development of IT processes (eg further development of internal CSV processes or certification of IT service areas according to ISO 27001: Information Security). Act as a key contact person as a CSV expert for customers & audits. Review & approval CSV & system documentation. Your Skills: At least 5 years of relevant professional experience including experience in IT Quality Assurance, Computer Systems Validation & Computer Software Assurance. A sound knowledge of IT Security, GDPR & IT Systems & Infrastructure. Experienced with Q-Systems (eg EU: Annex 11/FDA: 21CFR Part 11). Ideally experienced in the Medical Technology Sector. A knowledge of important IT Standards & Methods (eg ISO27001, ISO 80002-2, ITIL) or ISO 13485:2016 QMS for Medical Devices. Your Profile: Completed relevant Scientific or Technical University Degree. Strong communication skills, assertive & highly quality-oriented. Fluent English & good German language skills (to at least B2 Level) are a mandatory requirement.