Medical Device Consultant - QA , Schweiz Michael Bailey Associates - ZuriHELP
|Beschreibung:||Medical Device Consultant - QA|
|Firma:||Michael Bailey Associates - Zuri - Firma bewerten|
|Salär:||zu verhandeln CHF - 40 Std/Woche|
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&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges. Supports new product introduction as part of design transfer. Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans
Partners with Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; 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.
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