Quality Assurance Engineer (Fulltime/ Senior)

For a fast-growing international company In Venlo, we are looking for an experienced

Quality Assurance Engineer (Fulltime/ Senior)

The company is one of the world's leading companies in medical devices The Senior QA Engineer (MDR) 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 our client, CDC and RA/QA processes which will also make sure that all external and internal Stakeholders are aware and acting according to their roles and responsibilities.

Your key activities & accountabilities are:

• MDR QMS Process changes, support including where applicable owning processes.
• Independently working in teams regarding MDR Process and Organization Change Management.
• Preparing and Acquiring correct Management and RA or QA 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.

• Bachelor education (HBO+) and a minimum of 3-5 years’ experience in similar Quality-role;
• Knowledge of logistics processes and/or RAQA processes (Medical Device Regulation);
• Experience in implementing process changes regarding MDR;
• Knowledge/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;
• 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.

• Direct contract at our client;
• Good salary based on your experience (max.65k);
• Great career possibilities with meaningful growth opportunities;
• 10% bonus opportunity;
• 8,5% holiday allowance;
• 27 vacation day (+ 3 days if not sick for 12 months);
• Attractive stock purchase plan:
• Travel allowance;
• Subsidized lunch;
• Discount on gym membership and bicycle.

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 René van den Borst on 06 - 1881 7501.

Interested? Then click on the application button or send your resume to r.vdborst@suc6recruitment.nl

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