Head of Quality Assurance Brachy Business Line
Elekta · Veenendaal
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We don’t just build technology. We build hope for everyone dealing with Cancer.
Elekta is shaping the standard of care, together with healthcare providers, by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent, efficient and personalized care, addressing evolving patient needs. Through adaptive radiotherapy, precision treatment delivery and integrated workflows, Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com.
What You’ll Do At Elekta
As Head of Quality Assurance for our Brachy business line, you will provide strategic leadership for quality across the organization. Working closely with the business line Leadership Team, you will ensure that our quality strategy supports Elekta’s business objectives, regulatory responsibilities and commitment to patients and healthcare professionals.
You will lead and coordinate quality activities through functional and local quality teams, connecting with Elekta’s global Quality Assurance and Regulatory Affairs organizations when required. This is a senior leadership role with the opportunity to shape quality strategy, guide organizational change and strengthen a culture in which quality is embedded in how we work.
Responsibilities
- Develop and implement a Quality Assurance strategy aligned with the vision and long-term objectives of the Brachy business line and Elekta’s corporate quality strategy.
- Act as a strategic quality partner to the business line Leadership Team, contributing to planning, decision-making and business priorities.
- Lead the business line Quality Assurance team, setting clear priorities and creating the conditions for the team to perform effectively.
- Provide strategic, tactical and operational quality guidance to leaders and teams across the business line.
- Ensure that quality activities, programs and processes comply with Elekta’s Quality Management System, internal procedures and applicable regulatory requirements.
- Own and oversee the local implementation and continued effectiveness of Elekta’s Quality Management System.
- Lead management reviews and determine the appropriate frequency, scope and content for Nucletron B.V.
- Establish internal and external audit schedules and oversee the appropriate follow-up of findings.
- Make decisions on quality-related escalations and exceptions, and provide quality approvals where required.
- Support mergers and acquisitions by contributing quality expertise to due diligence, identifying potential risks and defining required post-acquisition actions.
- Monitor relevant legislative and regulatory developments, helping local organizations interpret changes and determine appropriate strategies.
- Represent Elekta in relevant interactions with international regulatory bodies where developments may affect the company’s business.
- Fulfil, directly or through appropriate delegation, the responsibilities associated with the Person Responsible for Regulatory Compliance role for Nucletron B.V.
- Contribute to the development of Elekta’s global Quality Assurance and Regulatory Affairs organization, processes and programs.
- Manage the agreed Quality Assurance budget and oversee performance and development within the team.
- Lead change by establishing direction, aligning priorities and supporting teams through implementation.
- Promote practical and innovative solutions to complex quality and business challenges.
- Demonstrate Elekta’s values and uphold its Code of Conduct, policies and ethical standards in all aspects of the role.
What You’ll Bring
- Significant leadership experience within Quality Assurance in a regulated medical device, healthcare or life sciences environment.
- Experience developing and implementing quality strategies that support both regulatory compliance and business objectives.
- Strong knowledge of quality management systems and applicable medical device regulations.
- Experience working with senior leadership teams and translating quality requirements into clear business priorities.
- Experience leading quality teams across functions, sites or international organizations.
- A strong understanding of regulatory compliance responsibilities, audits, management reviews and quality-related risk management.
- Experience supporting organizational change, business integration or mergers and acquisitions is an advantage.
- Ability to interpret regulatory and legislative developments and advise stakeholders on their potential business impact.
- Confidence representing an organization in discussions with regulatory authorities and other external bodies.
- Strong decision-making and problem-solving skills, with the ability to manage complex issues and competing priorities.
- A collaborative and inclusive leadership style, with a focus on developing teams, building trusted relationships and delivering results.
- Clear and effective communication skills in English, including the ability to communicate complex quality topics to different audiences.
- The professional background and expertise required to fulfil the applicable Person Responsible for Regulatory Compliance responsibilities.
What You’ll Get
In this role, you will work for a higher purpose: hope for everyone dealing with cancer, and access to the best cancer care for everyone, regardless of where they are in the world. You will be part of our international, innovative team and have opportunities to learn and develop.
An overview of some of our benefits for Veenendaal is provided below.
- 27 paid vacation days per year, plus 13 ATV days.
- Global bonus plan.
- Travel allowance.
- Metalektro pension fund, with contributions shared 50/50, supplemented by an additional pension plan with BeFrank for pensionable income above the applicable threshold.
- Insurance discounts.
- Active staff association.
- Tax benefits for fitness-centre memberships and bicycle purchases.
- Hybrid working, with at least four days per week on location.
Application Process
We look forward to receiving your application. Please submit your CV in English via the “Apply” button. We review applications on an ongoing basis, so we encourage you to apply as soon as possible.
We are an equal opportunity employer. We evaluate qualified applicants without regard to age, race, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.