Skills Profile
Assures product and process quality to medizintechnik industry standards. The role centres on Quality Management (ISO 9001), Failure Mode and Effects Analysis (FMEA) and Complaint Management (8D Method). Typical tools include AI Coding Assistants (Copilot/Claude). Sound knowledge of Audit Execution and Medical Device Regulation (MDR) is expected as well.Assures product and process quality to medizintechnik industry standards. The role centres on Quality Management (ISO 9001), Failure Mode and Effects Analysis (FMEA) and Complaint Management (8D Method). Typical tools include AI Coding Assistants (Copilot/Claude). Sound knowledge of Audit Execution and Medical Device Regulation (MDR) is expected as well.Assures product and process quality to medizintechnik industry standards. The role centres on Quality Management (ISO 9001), Failure Mode and Effects Analysis (FMEA) and Complaint Management (8D Method). Typical tools include AI Coding Assistants (Copilot/Claude). Sound knowledge of Audit Execution and Medical Device Regulation (MDR) is expected as well.
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Build, maintain and audit QM systems. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.Build, maintain and audit QM systems. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.Build, maintain and audit QM systems. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.
Build, maintain and audit QM systems. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.Build, maintain and audit QM systems. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.Build, maintain and audit QM systems. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.
Plan and conduct internal and external audits. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.Plan and conduct internal and external audits. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.Plan and conduct internal and external audits. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.
Plan and conduct internal and external audits. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.Plan and conduct internal and external audits. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.Plan and conduct internal and external audits. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.
Resolve complaints sustainably using 8D methodology. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.Resolve complaints sustainably using 8D methodology. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.Resolve complaints sustainably using 8D methodology. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.
Resolve complaints sustainably using 8D methodology. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.Resolve complaints sustainably using 8D methodology. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.Resolve complaints sustainably using 8D methodology. Covers forward-looking planning and prioritisation, clear alignment with all stakeholders, consistent follow-up on results and continuous improvement of processes.
Isolate, debug and durably fix defects. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.Isolate, debug and durably fix defects. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.Isolate, debug and durably fix defects. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.
Isolate, debug and durably fix defects. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.Isolate, debug and durably fix defects. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.Isolate, debug and durably fix defects. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.
Systematically analyse and prevent failure risks. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.Systematically analyse and prevent failure risks. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.Systematically analyse and prevent failure risks. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.
Systematically analyse and prevent failure risks. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.Systematically analyse and prevent failure risks. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.Systematically analyse and prevent failure risks. Covers preparing and quality-assuring the data, methodologically sound analysis, visualising results and presenting them audience-appropriately as a basis for decisions.
Implement MDR requirements in development and approval. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.Implement MDR requirements in development and approval. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.Implement MDR requirements in development and approval. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.
Implement MDR requirements in development and approval. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.Implement MDR requirements in development and approval. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.Implement MDR requirements in development and approval. This includes assessing specific cases, applying current requirements and case law, legally sound documentation, and advising business units in plain language.
Integrate AI assistants productively into development work. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Integrate AI assistants productively into development work. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Integrate AI assistants productively into development work. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Integrate AI assistants productively into development work. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Integrate AI assistants productively into development work. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Integrate AI assistants productively into development work. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Document equipment, maintenance and inspections to standard. Includes professional execution to standards and manufacturer specifications, appropriate measuring and testing steps, occupational safety, and complete documentation of the work performed.Document equipment, maintenance and inspections to standard. Includes professional execution to standards and manufacturer specifications, appropriate measuring and testing steps, occupational safety, and complete documentation of the work performed.Document equipment, maintenance and inspections to standard. Includes professional execution to standards and manufacturer specifications, appropriate measuring and testing steps, occupational safety, and complete documentation of the work performed.
Document equipment, maintenance and inspections to standard. Includes professional execution to standards and manufacturer specifications, appropriate measuring and testing steps, occupational safety, and complete documentation of the work performed.Document equipment, maintenance and inspections to standard. Includes professional execution to standards and manufacturer specifications, appropriate measuring and testing steps, occupational safety, and complete documentation of the work performed.Document equipment, maintenance and inspections to standard. Includes professional execution to standards and manufacturer specifications, appropriate measuring and testing steps, occupational safety, and complete documentation of the work performed.
Manage source code with Git and merge work in teams. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Manage source code with Git and merge work in teams. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Manage source code with Git and merge work in teams. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Manage source code with Git and merge work in teams. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Manage source code with Git and merge work in teams. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Manage source code with Git and merge work in teams. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Inspect incoming goods per inspection plan, document deviations and block nonconforming items.Inspect incoming goods per inspection plan, document deviations and block nonconforming items.Inspect incoming goods per inspection plan, document deviations and block nonconforming items.
Inspect incoming goods per inspection plan, document deviations and block nonconforming items.Inspect incoming goods per inspection plan, document deviations and block nonconforming items.Inspect incoming goods per inspection plan, document deviations and block nonconforming items.
Apply measuring equipment and document test results. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Apply measuring equipment and document test results. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Apply measuring equipment and document test results. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Apply measuring equipment and document test results. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Apply measuring equipment and document test results. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Apply measuring equipment and document test results. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Describe requirements in structured specification documents and align them with stakeholders.Describe requirements in structured specification documents and align them with stakeholders.Describe requirements in structured specification documents and align them with stakeholders.
Describe requirements in structured specification documents and align them with stakeholders.Describe requirements in structured specification documents and align them with stakeholders.Describe requirements in structured specification documents and align them with stakeholders.
Know relevant standards and apply them in projects. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Know relevant standards and apply them in projects. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Know relevant standards and apply them in projects. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Know relevant standards and apply them in projects. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Know relevant standards and apply them in projects. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Know relevant standards and apply them in projects. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Create manuals and specifications to standards. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Create manuals and specifications to standards. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Create manuals and specifications to standards. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Create manuals and specifications to standards. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Create manuals and specifications to standards. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Create manuals and specifications to standards. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Estimate effort (story points, planning poker) and plan sprints realistically.Estimate effort (story points, planning poker) and plan sprints realistically.Estimate effort (story points, planning poker) and plan sprints realistically.
Estimate effort (story points, planning poker) and plan sprints realistically.Estimate effort (story points, planning poker) and plan sprints realistically.Estimate effort (story points, planning poker) and plan sprints realistically.
Organise backlogs, boards and docs in Jira and Confluence. Covers confident day-to-day use: data maintenance and quality, configuration of processes and workflows, analyses and reports, and onboarding of new users.Organise backlogs, boards and docs in Jira and Confluence. Covers confident day-to-day use: data maintenance and quality, configuration of processes and workflows, analyses and reports, and onboarding of new users.Organise backlogs, boards and docs in Jira and Confluence. Covers confident day-to-day use: data maintenance and quality, configuration of processes and workflows, analyses and reports, and onboarding of new users.
Organise backlogs, boards and docs in Jira and Confluence. Covers confident day-to-day use: data maintenance and quality, configuration of processes and workflows, analyses and reports, and onboarding of new users.Organise backlogs, boards and docs in Jira and Confluence. Covers confident day-to-day use: data maintenance and quality, configuration of processes and workflows, analyses and reports, and onboarding of new users.Organise backlogs, boards and docs in Jira and Confluence. Covers confident day-to-day use: data maintenance and quality, configuration of processes and workflows, analyses and reports, and onboarding of new users.
Create models, simulations and analyses in MATLAB/Simulink. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Create models, simulations and analyses in MATLAB/Simulink. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Create models, simulations and analyses in MATLAB/Simulink. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Create models, simulations and analyses in MATLAB/Simulink. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Create models, simulations and analyses in MATLAB/Simulink. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Create models, simulations and analyses in MATLAB/Simulink. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Plan, run and evaluate user tests. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Plan, run and evaluate user tests. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Plan, run and evaluate user tests. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
Plan, run and evaluate user tests. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Plan, run and evaluate user tests. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.Plan, run and evaluate user tests. In practice this covers independent execution, quality assurance of one's own results, and close alignment with adjacent roles and interfaces.
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