Senior RAQA Specialist (MDR)
- Venlo, Netherlands
The Job's Mission
The Senior RAQA Specialist is owner of MDR related QMS setup and processes and acts independently as a liaison for the CDC (Central Distribution Center) in change processes regarding Quality Management System, Value Added Services and Continuous Improvements. Also in such a way that the organization keeps meeting the Legal, Corporate, ISO 13485 and FDA RAQA requirements. This role ensures a standardized and structured approach to Stryker, CDC and RAQA processes which will also make sure that all external and internal Stakeholders are aware and acting according to their roles and responsibilities.
Key Activities & Accountabilities
The Senior RAQA specialist MDR is responsible for:
- MDR QMS Process changes, support including where applicable owning processes.
- Independently working in teams regarding MDR Process and Organization Change Management.
- CAPA process handling, tracking progress and status
- Preparing and Acquiring correct Management and RAQA approvals where needed.
- MDR QMS processes reporting to stakeholders in and outside CDC..
- Support the Organization regarding Quality Policy, QMS, Regulatory and Quality in general
- Any other MDR related RAQA activities as defined by the Senior RAQA Manager.
- In depth knowledge of EU Medical device Regulation ( MDR ) and experience implementing change regarding MDR
- A minimum of 3-5 years' experience in similar role in the Medical Device Industry
- Experience of working in an ISO13485, FDA Medical Devices or Quality function related environment.
- Customer and Service minded, Hands-on, Proactive.
- Structured, eye for detail and precise.
- Team player and able to positively influence others.
- Vocational Education (HBO+).
- Education in or knowledge of logistics processes and/or RAQA processes
- In depth knowledge of ISO 13485 and/or FDA Medical regulations.
- Fluent in English, Dutch and/or German would be a plus.
- MS Office advanced experience.
- ERP software experience; Experience with SAP and /or Oracle would be a plus.
- Excellent communication and interpersonal skills.
- Experience with International Standards (e.g. ISO/FDA)
Reporting / Communication lines
- Reports to Senior RAQA Manager CDC EU and USA.
- Stryker CDC communication: CDC Operations, CDC RAQA, Employees.
- External communication: Stryker RAQA sources and suppliers.
Work From Home: Occasional
Travel Percentage: 10%
Back to top