I am currently representing a client who are looking for an experienced Quality Assurance Manager to join their team, based in Paris! The company are an innovative and exciting organisation who have an excellent reputation in France and also Globally! They are ideally looking for a candidate with Medical Device and Validation expertise to accompany a strong Quality background. The company are actively looking to expand at present and opportunities for personal progression are available.
As the QA/RA Manager you will work as part of a small team and be responsible for day to day running of the Quality and Regulatory department. Using your experience and knowledge within the Medical Device sector, you will maintain the Quality Management system in place and oversee the Regulatory submissions as this company look to bring their Ophthalmic devices to new markets!
- To manage and maintain the work related to the functioning of the Quality System, in compliance with ISO 13485/9001
- Responsible for all Regulatory matters, including technical files, CE marking and overseas registration
- Monitoring supplier performance, inspection failures and customer complaints.
- Maintain and update the required documentation, including drawings and CAPAs.
- Allocation of projects/tasks, ensuring that every member of your team has a clear objective within a defined time frame.
- Liaise with corporate and external contacts with regards to Quality issues.
- Involved with Labeling, Packaging, Regulatory processes and validations.
- Excellent understanding of European Medical Device Directive requirements.
- Knowledgeable of: EN ISO 13485, ISO 9001
- A strong Regulatory background.
- Be Self-motivated and able to work independently or as part of a team
- Experience of managing Regulatory/Quality teams.
- Certified internal Auditor.
- Experience working with class IIa Medical Devices.
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley – Advanced Clinical Recruitment
+44 (0) 114 294 5008
LinkedIn Search: Sam Caley Quality Assurance
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