Quality Assurance Engineer

  • Locatie
  • Vakgebied
  • Uren per week
    32-40 uur
  • Salaris
    € 4.350,00/Maand

Do you have experience in quality assurance and you like contacts at the local level but also outside with external parties? Do you want to work within a company who is constantly changing, with various product groups and various process systems and projects? Then read on!

The Quality Assurance engineer plays an active role to ensure that QMS requirements are in accordance with the appropriate regulations concerning medical devices. The QA engineer is responsible for the maintenance and continuous development and implementation of the Quality system processes with a strong focus on end-to-end business processes for EMEA distribution. ISO13485, GDP and EU-MDR Importer and Distributor processes are at the core of the activities. Pro-active monitoring of regulatory requirements and ensuring applicable implementation is key. The QA engineer collaborates with the local and global QA team and a variety of stakeholders within the international organization. Using reporting and data-analysis skills the QA engineer plays an important role in providing advice and direction for quality related topics and processes.


  • Implement and maintain Quality Management System (QMS) documents and processes to ensure compliance with regulatory and corporate requirements.
  • Ensure compliance to EU-MDR Importer and Distributor responsibilities
  • Contribute to Value Added Services performed from QA perspective.
  • Assist with implementing and maintaining a single Warehousing & Distribution Management System (QMS) strategy.
  • Contribute and facilitate in projects, change control, CAPA, and NC.
  • Coordinates/performs internal audits and contributes to identifying and correcting internal deviations.
  • Follow QMS procedures, always contribute to quality, proactively and on time.
  • Monitor and analyze the QMS processes for efficiency and improvement opportunities and implement actions to address the identified gaps.
  • Acts as a back-up contact for audit/inspection and QA manager as required.
  • Work closely with internal and external stakeholders and contribute to improve cross-functional processes.
  • Follow safety procedures, report dangerous situations, incidents & accidents; contribute to safety as the first priority.

The QA team consists of: 1 QA manager, 1 junior QA for non-conforming products, 3 QA employees working on documentation management and training, on data coordination and 1 QA specialist doing supplier control. In addition, there is a global QA Manager at headquarters.

Waar ga je werken?

An international company and market leader in dental products and technologies. The distribution center is located in Sevenum, near the border of Venlo. You work within a nice, informal working atmosphere with great colleagues. It is a well-organized, clean warehouse. A nice company with committed employees.

There is always fresh fruit and soup waiting for you! Regularly fun activities are organized for all employees, recently there was a pizza day and in the summer a big staff party for all 160 employees!

Wat vragen wij?

What do we ask?

  • Bachelor’s Degree in Business administration / Quality Assurance / Life Sciences or equivalent through experience
  • Min. 2-5 years work experience in quality assurance regulated environment
  • Knowledge/experience in an ISO setting (e.g. ISO13485, FDA 21CFR820, ISO9001, EU-MDR and other European regulations)
  • Experience with medicines and / or medical devices in a regulated environment is a plus
  • Good experience with writing, changing and implementing documentation for QMS
  • Highly self-motivated and a positive ‘’can do’’ professional attitude, self-starting, not afraid of a challenge and hands-on
  • Strong written, verbal and interpersonal communication skills (minimum English, Dutch and/or German are a pre)
  • Ability to work well within a dynamic international team environment
  • Critical and analytical problem solving skills
  • Strong ability to use and analyze data to identify trends and opportunities for improvement on quality aspects
  • Strong ability to multi-task and juggle various projects effectively
  • Excellent organizational and time management skills
  • Strong computer skills

What do we offer?

  • This is a procedure based on Permanent Recruitment. This means that you will be employed by our client immediately.
  • A full-time job with flexible working hours in day shift. Preferably 40 hours per week. 32 hours may be negotiable depending on the candidate.
  • A pleasant, informal working environment with plenty of development opportunities where personal input and freedom to shape the function is encouraged.
  • A good salary around € 4350,- gross/month. Bonus scheme of 5-10% (50% depending on personal objectives achieved and 50% on company results achieved).
  • Travel allowance € 0,21 cents/km. Possibility to participate in collective health insurance Zilveren Kruis, compensation up to € 250 per year for dentists. Possible participation in cycling project In addition, 28 holidays, 8% vacation money.

Are you interested or would you like to know more about this job?

Please respond with an English CV by clicking on the application button. You are applying for a permanent position, where you will be employed directly by our client. Your application and registration will be processed as such! 

Would you first like more information? Then call or email our Consultant Recruitment & SeIection: Karien Cleven on 06-25179734 or karien.cleven@adecco.nl