Job Responsibility：
General Responsibilities
• Ensure company compliance with internal Supplier Management procedures.
• Guarantee supplier adherence to applicable specifications global medical device regulations.
• Drive continuous improvement across supplier quality tools, metrics, processes.
• Educate suppliers on product standards, intended uses, technical expectations.
• Provide quality oversight fcross-functional initiatives, including cost-reduction projects driven by Purchasing.
Pre-Production Activities (New Product Development & Onboarding)
• Supplier Selection & Qualification: Partner with R&D, Operations, Purchasing to qualify suppliers via technical audits.
• Specification & Process Controls: Collaborate with R&D to define, review, approve component specifications, ensuring critical-to-quality (CTQ) characteristics required process controls are identified.
• Technical Capability Development: Develop supplier technical capabilities, control plans, readiness throughout the product development life cycle.
• Quality Agreements & Risk Management: Establish supplier quality requirements, execute Quality Agreements, verify effective risk control measures at the supplier site.
• Incoming Inspection Planning: Assist in establishing incoming inspection plans sampling strategies fcomponents, sub-assemblies, finished goods.
Post-Production Activities (Sustaining & Lifecycle Management)
• Corrective Actions (SCAR): Issue manage Supplier Action Requests (SAR/SCAR), ensuring thorough root cause analysis, timely implementation, verification of corrective actions.
• Change Management: Lead the evaluation, risk assessment, execution of Supplier Change Requests (SUCRs).
• Supplier Audits: Conduct periodic supplier quality audits according to the audit schedule track corrective action plans to closure.
• Performance Monitoring & Data Analytics: Track supplier KPIs, generate quality scorecards, analyze quality trends, present performance metrics during Quality Management Reviews (QMR).
This list of functions is not exhaustive, other tasks inherent to the position may be performed at the request of the line manager and/in case ofganizational change.
Job Requirements：
Qualified Engineer (Industrial equivalent).
Post graduate studies in matters like Industrial Engineering, Quality, Supplier Management others related to the role.
Minimum five (5) years of work experience in highly regulated manufacturing environments similar roles.
Knowledge of requirements EU MDR, FDA, GMP, ISO 13485
Knowledge of use of Quality tools/methodologies (CAPA, Data Analysis, Statistical Techniques)
Knowledge of process analysis continuous improvement tools [Lean, Six-Sigma, Poka-Yoke / ErrProofing, Measurement System Analysis, Process Failure Mode Effects Analysis (PFMEA)]
Audit Techniques
Knowledge of Industrial processes
Ability to negotiate "win-win" situations with internal customers external suppliers
Ability to work in a highly matrixed, geographically culturally diverse business environment
Ability to participate in cross-functional teams work with others
Resultsiented & High degree of responsibility accountability
Leadership Skills
Excellent verbal written communication Skills
Analytical thinking & Prioritization skills
Fluent in English (written spoken)
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