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.