Supplier Management : Maintain and implement supplier management processes to ensure strong and effective relationships.
Selection and Evaluation : Participate in the selection, qualification and periodic evaluation of suppliers according to established procedures.
Complaints and Notifications : Ensure the processing and follow-up of supplier complaints and change notifications within the required timeframes.
Assessment Meetings : Organize and participate in change impact assessment meetings.
Audits : Plan, organize and carry out supplier and distributor audits.
Quality : Handle quality events (non-conformity, OOS, change control, CAPA) in collaboration with other departments.
Continuous Improvement : Lead problem-solving groups and support continuous quality improvement projects.
Internal Communication : Feed back information from the various departments within the Quality Department.
Quality Referent : Intervene on projects as a quality referent, review new design specifications and provide your input on component quality and manufacturing feasibility.
Investigations and Corrective Actions : Investigate supplier material failures and develop corrective action plans if necessary.
Acceptance Criteria : Develop material acceptance criteria and activities.
Profile
Mastery of Quality Standards ISO 9001 & 13485
Knowledge of MDR
Certified Lead Auditor 13485
Knowledge of Quality tools (5P, 5M, 8D,...) and risk analysis methods
English : Good comprehension and writing skills (minimum level B2)
Basic training : CFC or equivalent
Professional experience required : Minimum 5 years of experience in quality in the pharmaceutical and / or medical device industry