(Senior) RA/QA Specialist (MDR)
- Logistiek/ transport / inkoop ,
- Management en directie
- Noord Limburg
For a fast-growing international company, we are looking for an experienced RA/QA Specialist (MDR). The company is located in Venlo and is one of the world's leading companies in medical devices. As RA/QA Specialist you are the owner of MDR related QMS setup and processes. Together with the company, you will make sure legal, corporate, ISO and FDA requirements are kept. You will have a standardized and structured approach to RA/QA processes which will also make sure that all external and internal stakeholders are aware and acting according to their roles and responsibilities.
- 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.
- Vocational Education (HBO+)
- Education in or knowledge of logistics processes and/or RAQA processes
- Indepth knowledge of ISO 13485 and/or FDA Medical regulations
- Excellent knowledge of the Dutch and English language: 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)
What you get in return
- A direct contract
- Good salary based on your experience (max.55k)
- Great career possibilities with meaningful growth opportunities
- 10% bonus opportunity
- 8,5% holiday allowance
- 27 vacation days
- Travel allowance
- Subsidized lunch
- Discount on gym membership and bicycle
A Great Place To Work
And yes that's 100% true! Fortune named this company A Great Place To Work for the seventh year in a row, ranking it in the top 10! This company is known for its innovative products and solutions in the healthcare industry. Founded in 1941 this company has expanded to over 30 countries worldwide and is still growing. Your workplace will be located in the European Distribution Center (EDC) in Venlo.
Want to know more? Then contact Rene van den Borst on 06 - 1881 7501.
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