The RA/QA Specialist will operate as a member of the RA/QA Team with a mandate to maintain Service and Product Complaint reporting and Product Field Action & Product Commercial Hold Execution.
Key Activities & Accountabilities:
Within the 4 key pillars of our organization the RAQA specialist is responsible for:
Secure day to day:
- QMS Process Ownership including where applicable Document and Record Control.
- CAPA process handling, tracking progress and status
- Support the Organization regarding Quality Policy, QMS, Regulatory and Quality in general
- Any other RAQA activities as defined by the RAQA Manager.
Strengthening the base:
- QMS processes reporting to stakeholders in and outside CDC.
New Business Needs/ Opportunities:
- Supporting M&A and other business integration
Profile & Competences:
- Vocational Education (MBO+)
- A minimum of 1-3 years’ experience in similar role
- Education in or knowledge of logistics processes and/or RAQA processes
- Experience of working in the Medical Devices industry would be a plus.
- Experience of working in an ISO13485, FDA medical devices or Quality function related environment.
- Customer and Service minded, Hands-on, Proactive.
- Excellent communication and interpersonal skills.
- Team player and able to positively influence others
Ulrike De Smedt
+32 15 858 034