Medical Device Compliance Officer
Vor 3 Tagen
We are recruiting a highly skilled Medical Device Compliance Officer to join our team at Teoxane SA. As a key member of our quality team, you will be responsible for ensuring the compliance of our medical devices with regulatory requirements.
About the Job:This is a challenging role that requires strong analytical and communication skills. You will be involved in the selection, qualification, and periodic evaluation of suppliers according to established procedures. You will also be responsible for maintaining and implementing supplier management processes to ensure strong and effective relationships.
Main Responsibilities:- Maintain and implement supplier management processes to ensure strong and effective relationships.
- Participate in the selection, qualification, and periodic evaluation of suppliers according to established procedures.
- Ensure the processing and follow-up of supplier complaints and change notifications within the required timeframes.
- Organize and participate in change impact assessment meetings.
- Plan, organize, and carry out supplier and distributor audits.
- Handle quality events (non-conformity, OOS, change control, CAPA) in collaboration with other departments.
- Lead problem-solving groups and support continuous quality improvement projects.
- Feed back information from the various departments within the Quality Department.
- 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
- Good comprehension and writing skills (minimum level B2)
- CFC or equivalent
- Minimum 5 years of experience in quality in the pharmaceutical and/or medical device industry
The ideal candidate will be autonomous, rigorous, and have a strong team spirit. If you are passionate about quality and supply chain management, we encourage you to apply for this exciting opportunity.
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