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Medical Device Consultant - QA
Eingestellt von Michael Bailey Associates - Zurich
Gesuchte Skills: Support, Consultant
Projektbeschreibung
Tasks:
Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc. Champions compliance to applicable Global Regulations and standards (eg QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits. Partners with R and the investigation/correction of process failures when needed. Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan. Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes. Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. Develop, interpret and implement standard and non-standard sampling plans. Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis. Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data. Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits. Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs. Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc. Champions compliance to applicable Global Regulations and standards (eg QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits. Partners with R and the investigation/correction of process failures when needed. Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan. Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes. Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. Develop, interpret and implement standard and non-standard sampling plans. Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis. Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data. Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits. Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs. Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Organisation/Management, Sonstiges