Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Responsibilities:
- Qualification evaluation and continuous monitoring of suppliers in accordance with ISO 9001 requirements applying risk-based supplier classification and performance management principles;
- Ensuring that supplier controls meet the expectations of customers operating under ISO 13485 and/or GMP environments;
- Management of supplier-related nonconformities including structured root cause analysis corrective actions and effectiveness verification;
- Oversight of externally provided processes with focus on documentation control traceability validation support and compliance-relevant records;
- Evaluation and approval of supplier change notifications including structured risk assessment and customer impact analysis;
- Driving supplier quality performance improvement through KPI monitoring escalation management and development initiatives;
- Planning and execution of supplier audits when required including preparation for customer audits and support during external inspections.
Requirements:
- Degree in Engineering Quality Management or a related technical discipline;
- Proven experience in supplier quality management within an ISO 9001 certified environment;
- Solid understanding of ISO 13485 and/or GMP requirements particularly regarding supplier control documentation traceability and regulatory expectations;
- Strong knowledge of quality tools and methodologies such as FMEA 8D Root Cause Analysis risk assessment and statistical methods;
- Experience with nonconformance management CAPA processes risk-based thinking and structured change control;
- High level of self-organization engagement and ability to collaborate effectively in cross-functional and customer-facing environments;
- Strong analytical skills structured working style and a clear sense of ownership and accountability;
- Proficiency in Microsoft 365 applications (Excel Word PowerPoint Teams) and experience with quality management or ERP systems;
- Fluent English in written and spoken communication.
We offer:
- Competitive remuneration annual incentive plan bonus scheme healthcare company pension and a range of employee benefits;
- Employment with an innovative forward-thinking organization and outstanding career and development prospects;
- Exciting company culture that stands for integrity intensity involvement and innovation.
Required Experience:
IC
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety StandardsJob DescriptionResponsibilities:Qualification evaluation and continuous monitoring of suppliers in accordance with ISO 9001 requirements applying risk-based supplier classificat...
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Responsibilities:
- Qualification evaluation and continuous monitoring of suppliers in accordance with ISO 9001 requirements applying risk-based supplier classification and performance management principles;
- Ensuring that supplier controls meet the expectations of customers operating under ISO 13485 and/or GMP environments;
- Management of supplier-related nonconformities including structured root cause analysis corrective actions and effectiveness verification;
- Oversight of externally provided processes with focus on documentation control traceability validation support and compliance-relevant records;
- Evaluation and approval of supplier change notifications including structured risk assessment and customer impact analysis;
- Driving supplier quality performance improvement through KPI monitoring escalation management and development initiatives;
- Planning and execution of supplier audits when required including preparation for customer audits and support during external inspections.
Requirements:
- Degree in Engineering Quality Management or a related technical discipline;
- Proven experience in supplier quality management within an ISO 9001 certified environment;
- Solid understanding of ISO 13485 and/or GMP requirements particularly regarding supplier control documentation traceability and regulatory expectations;
- Strong knowledge of quality tools and methodologies such as FMEA 8D Root Cause Analysis risk assessment and statistical methods;
- Experience with nonconformance management CAPA processes risk-based thinking and structured change control;
- High level of self-organization engagement and ability to collaborate effectively in cross-functional and customer-facing environments;
- Strong analytical skills structured working style and a clear sense of ownership and accountability;
- Proficiency in Microsoft 365 applications (Excel Word PowerPoint Teams) and experience with quality management or ERP systems;
- Fluent English in written and spoken communication.
We offer:
- Competitive remuneration annual incentive plan bonus scheme healthcare company pension and a range of employee benefits;
- Employment with an innovative forward-thinking organization and outstanding career and development prospects;
- Exciting company culture that stands for integrity intensity involvement and innovation.
Required Experience:
IC
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