The QA Systems Governance Specialist oversees the global use of the Quality Management System (QA tool) to ensure safe and effective products and services.
A role that counts: Optimize our global Quality Management System that helps to underpin innovative cancer treatments worldwide.
Elekta 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, 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.
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.
An attractive offer from a great organization
Elekta 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.
- 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.
We look forward to hearing from great candidates
Please contact Wilma de Koning (Quality Assurance Manager) or Arjette Poot (HR Business Partner), for more information about this position, phone number +31 (0)6 53996155. You can apply via the ''Apply'' button.
Elekta 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 Elekta 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. Elekta employs 3,600 people around the world. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm.
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