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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
Autonomous, rigorous, with a strong team spirit

Senior Supplier Quality Engineer