Job Description
Main Activities:
* Maintain and Implement Effective Supplier Management Processes to Foster Strong Relationships.
* Participate in Supplier Selection, Qualification, and Periodic Evaluation according to Established Procedures.
* Ensure the Processing and Follow-up of Supplier Complaints and Change Notifications within Required Timeframes.
* Organize and Participate in Change Impact Assessment Meetings.
* Plan, Organize, and Carry out Supplier and Distributor Audits.
* Collaborate with Other Departments to Handle Quality Events such as Non-Conformity, OOS, Change Control, and CAPA.
* Lead Problem-Solving Groups and Support Continuous Quality Improvement Projects.
* Foster Internal Communication by Sharing Information from Various Departments within the Quality Department.
* Serve as a Quality Referent on Projects, Reviewing New Design Specifications and Providing Input on Component Quality and Manufacturing Feasibility.
* Investigate Supplier Material Failures and Develop Corrective Action Plans if Necessary.
* Establish Material Acceptance Criteria and Related Activities.
Key Profile Requirements:
* Mastery of Quality Standards ISO 9001 & 13485.
* Knowledge of Medical Device Regulations (MDR).
* Certified Lead Auditor 13485.
* Proficiency in Quality Tools such as 5P, 5M, 8D, and Risk Analysis Methods.
* Excellent English Comprehension and Writing Skills (Minimum Level B2).
* Basic Training: CFC or Equivalent.
* Minimum 5 Years of Experience in Quality within the Pharmaceutical and/or Medical Device Industry.
* Autonomous, Rigorous, and Strong Team Spirit.