Quality Assurance Systems Specialist

  • Veenendaal
  • HBO
  • Salary indication €3200-4800
  • 40 Hours per week
  • Fulltime
  • #1AV0027631

About the job

A role that counts: Optimize our global Quality Management System that helps to underpin innovative cancer treatments worldwide.
This company is the leading innovator of precision radiation technology that helps clinicians to focus their attention where it truly matters so that they improve, prolong and save the lives of people with cancer and brain disorders. This demands the highest levels of regulatory compliance and Quality Assurance (QA). What could be more satisfying than playing an essential role in this effort by acting as the bridge between our QA team and the IT specialists, ensuring that requirements are implemented successfully as we develop new modules within our rigorous Quality Management System (QMS)?

Quality Assurance Systems Governance Specialist
Veenendaal, fulltime 40 hours a week

This is a new role within a recently restructured QA organization and you will join a global QA team of seven that has deep knowledge of the standards and regulations for the medical devices industry. The QA team is responsible for a globally standardized new QMS and also for the introduction of all new modules within the system.

Within this context, your core task is to perform governance for QA tools. In doing so you use stakeholder input and the team’s knowledge as you work with other team members, internal vendors and IT to translate system requirements into improved QMS modules that ensure our ability to develop and market safe and effective products and services. This involves a variety of projects and compliance activities as you:

  • Advise on system configurations and data management;
  • Analyze process data and trends and drive optimization and improvement;
  • Work with stakeholder teams to define system requirements and to support process and system changes;
  • Participate in authorization, verification and validation activities related to the QA tools;
  • Establish (monthly) metrics and reports for QA tools;
  • Deliver trainings as and when necessary.

Communication is key
You will work within a team that knows all there is to know about QA. So although it is useful if you have previously worked within QA it is not essential as the team can bring you up to speed with specific knowledge. Essential in this role is your ability to deploy the multi-facing communication skills necessary to accurately interpret and transmit requirements and requests from multiple stakeholders. This will optimize our ability to develop new modules or make changes to existing modules so that we maintain a standardized and outstanding QMS that can be used by all Elekta employees for their own area of expertise or work area.

An influential role
Because the team is relatively small this role represents an opportunity to have a real impact on the priorities and planning roadmap for the development/improvement of the QMS tool. To seize this opportunity you should be a confident and open personality who can communicate effectively in English across all channels with people at all levels. You should also be sensitive to other cultures and able to embody a service-focused approach towards the team’s many internal clients.

Job requirements

We also ask you to bring:

  • A Bachelor’s degree in an area such as ICT, Business IT, Industrial Engineering or equivalent, or demonstrable experience in a similar role;
  • Training and experience in relevant standards such as GDPR, with knowledge of medical devices standards (e.g. ISO) a benefit;
  • Ability to translate regulations into meaningful business requirements while taking the initiative and meeting tight deadlines;
  • Experience with quality improvement tools and techniques is a plus (e.g. Lean, Six Sigma, DOE, Statistical Methods, etc.);
  • A structured approach to problem solving with an appreciation of quality tools and techniques;
  • Willingness and ability to travel occasionally.

About the company

An attractive offer from a great organization
The company is an informal, forward-thinking and multicultural international organization that is fully focused on the wellbeing of our employees. While this is an independent role you will work in a spirit of cooperation and mutual support with colleagues and your local managers. In addition there are numerous possibilities for growth and development within both the Netherlands and our global teams. Above all, you will always know that you are contributing to the improvement of cancer treatments worldwide.

About the company
The company is proud to be the leading innovator of equipment and software used to improve, prolong and save the lives of people with cancer and brain disorders. Our advanced, effective solutions are created in collaboration with customers, and more than 6,000 hospitals worldwide rely on this company technology. Our treatment solutions and oncology informatics portfolios are designed to enhance the delivery of radiation therapy, radiosurgery and brachytherapy, and to drive cost efficiency in clinical workflows. The company employs 3,600 people around the world. Headquartered in Stockholm, Sweden, They are listed on NASDAQ Stockholm.

What we offer

Further benefits include:

  • A permanent contract and a competitive salary that matches your experience;
  • Profit-sharing arrangement: max 16% on a yearly basis (9% average in recent years);
  • 8% holiday allowance;
  • 27 vacation days and 13 ADV days per year;
  • Travel allowance for home-work travel;
  • Tax-advantageous fitness package;
  • Good company restaurant and regular opportunities to socialize within the company

Find your job

Is this not the job you where looking for? We have more vacancies that might be interesting!

Vestigings gegevens

Start People Ede
Telefoonweg   76  
6713 AL, Ede

Ede@startpeople.nl
0318615588

Gratis inschrijven

Wil jij op de hoogte blijven van onze nieuwe vacatures?

Schrijf je dan nu gratis in

Frequently asked questions

Yes, we are a member of ABU: the branch organization of the temporary employment sector. This organization guarantees that its members act according to the Dutch law. 
You are more than welcome at our office in Venlo, where our recruiters can talk to you in either Dutch, English, German and/or Polish.
If you work via Start People it is possible to, I some cases,  use one of our collective health insurance policies. However, if you want to stay in The Netherlands for a longer period of time, we advise you to arrange health insurance yourself.  
Some companies we work with only offer day shifts, but the most companies offer several shifts (morning-, day and night shifts). It is often not possible to work structurally in one specific shift.
Unfortunately, one of these three languages is required to find a job via Start People. It is important that you can communicate with our colleagues and your manager at work.
Yes, you can choose between a weekly or a 4-weekly payment of your salary.
If you want to work in The Netherlands, you should be able to arrage your own transportation. Also, traveling together with other people is not preferred due to the flexibility you need for several jobs. 
Unfortunately, Start People does not offer housing. If you wish to work for Start People, you need to arrange housing in the Netherlands or in the Dutch border area.

If you have the intention to stay in the Netherlands for more than four months, you must register in the personal records database of the city you live in. To do this, go to the town hall of the city where you are going to live. You will then receive a citizen service number (BSN). With this number, your employer can register you, for example, at the Tax Authorities/ Doctors, hospitals and pharmacies can also ask you for your BSN. For more information, visit the website of the City where you live or visit www.burgerservicenummer.nl.

If you intend to stay in the Netherlands for less than four months, registration in to the personal record database is not obligated. If you still want a citizen service number, you must register in the personal record database of the city you live in. 

We can help you make an appointment to get your BSN number, but you must go to the appointment yourself. 
You need a valid ID, BSN number on an original document from either the Tax Authorities or City (Hall) you are registered in, and a European bank account number (IBAN) in your name.
In The Netherlands, it is not allowed to charge money for job placement services. Therefore, our services are free.