ViCentra is at the core of innovation in the day-to-day management of Diabetes. People dealing with this condition have great benefit from superior accurate insulin delivery and control. ViCentra is providing exactly this in a discrete, simple way that leaves room for choice on how to live life ‘in your own way’.

Founded in 2013 in Utrecht, The Netherlands, ViCentra is a leading commercial company focused on the development, manufacturing and commercialisation of the Kaleido insulin pump designed to help people with diabetes live life on their own terms. CE Marking is received last year and ‘crossing the ocean’ to the US markets is being planned.

Driven by a belief in the power of innovative healthcare products that put people first and a desire to be meaningfully different, Kaleido aims to reduce the impact that diabetes can have on daily life. ViCentra is preparing for the next phase in its growth, scaling up both its operations and its internal capabilities, in order to deliver on its promise of excellence.

As part of this journey, ViCentra is strengthening its leadership in Quality. With a growing portfolio, increasing complexity in processes, and ever-more ambitious product development and transfer activities, the company is looking to appoint a:

Director Quality Engineering – Product & Process Development and Transfer (PPDT)

Reporting into the VP QA/RA, the Director will lead the Quality Engineering team that is responsible for ensuring that all product designs, manufacturing processes and supporting technologies are developed in compliance with applicable regulatory standards and in alignment with ViCentra’s core values. You will be responsible for defining and driving the quality strategy across the Product & Process Development and Transfer function (PPDT), shaping the future of Kaleido’s technical foundation and ensuring innovation is always underpinned by quality and compliance.

This is a strategic and people-driven leadership role. As ViCentra continues to scale, the Director will play a crucial part in embedding a strong quality culture across the organisation, whilst building high-performing, cross-functional collaboration across development, operations and regulatory teams. It is an exciting opportunity to lead in a fast-growing environment where bold ideas and a strong quality mindset are essential to success.

Job Purpose

As Director Quality Engineering PPDT, you are accountable for ensuring that the quality strategy and execution in product design, process development and transfer are robust, future-ready and fully compliant. Your role is both strategic and operational: translating regulatory demands into practical implementation, coaching and developing your team, and collaborating with other leaders to drive high-quality outcomes in new products, processes and technologies.

You will:

• Own the quality strategy related to product and process development, and ensure its implementation across projects and activities.
• Lead a team of skilled Quality Engineers, ensuring the right competencies are developed, recruited or externally sourced.
• Build a strong quality mindset and ensure that PPDT’s outputs comply with regulations (ISO 13485, EU MDR, 21 CFR 820) and internal standards.
• Represent PPDT in cross-functional project meetings, audits and senior leadership discussions.
• Proactively identify risks, drive mitigations and support the business in maintaining development timelines without compromising quality.

Responsibilities

• Define and execute the PPDT Quality Strategy in alignment with company objectives.
• Ensure that all product and process development activities, including validation and transfer, meet internal and regulatory quality requirements.
• Lead and coach a growing team of Quality Engineers, fostering a high-performance culture and ensuring clear development paths.
• Actively monitor and manage resource allocation across projects, balancing workload and competence needs.
• Oversee key quality deliverables in development and transfer processes, including risk management, process validation, change control, and quality control strategies.
• Engage in ongoing cross-functional collaboration to ensure alignment on methods, timelines and expectations.
• Identify and escalate risks to timelines or compliance early, and take ownership for remediation or mitigation activities.
• Represent PPDT in internal, customer and external audits.
• Monitor evolving regulations and standards, and translate these into updated processes and training.
• Contribute to ViCentra’s continuous improvement culture by supporting improvement initiatives, CAPAs, training and QMS projects.

You

Required:

• Bachelor’s degree in a technical or scientific field.
• 10+ years of experience in product, process and/or technology development in a regulated medical device or comparable environment.
• 5+ years of prior leadership experience, including managing technical teams.
• Deep understanding of quality regulations: ISO 13485, MDR, 21 CFR 820, and GMP.
• Excellent project and people management skills, with the ability to balance operational demands and long-term strategic planning.
• Experienced in cross-functional collaboration, with strong influencing and stakeholder management skills.
• Strong ethics and judgement, with a hands-on and pragmatic approach.
• Fluent in English.

Desirable:

• Master’s degree in engineering, science or business.
• Previous experience in the diabetes or infusion therapy space.
• Experience in a scale-up environment.
• Background or training in regulatory, finance or marketing.

Core Competencies

• Be Bold
• Build Trust
• Deliver Excellence
• Focus on the Customer

Role-specific Competencies

• Strategic Thinking
• Attention to Detail
• Problem Solving and Analytical Thinking
• Communication and Interpersonal Skills
• People Leadership
• Organisation and Decision-Making

Terms and Conditions

• The role is full-time and based in Utrecht, The Netherlands.
• ViCentra offers hybrid working and a flexible work schedule where possible.
• Compensation will be in line with the responsibility of the role and the company’s scale-up context.
• Relocation assistance and compensation are provided as part of the offer.

Closing Remarks

Since the growth of the company is only limited by the speed it can ramp up production and introduce innovations and new products, this role is extremely important. We are thus looking for ‘overqualified’ people, able to fulfill a higher, more senior level. Please bear in mind that resources are still limited while investments for growth are outpacing growth in turnover. Undoubtedly, this will change in the coming few years but in the meantime, we need professionals who can absorb the speed with which ViCentra is developing.

ViCentra is working with Kennedy Executive Benelux to conduct this appointment process.

If you have questions about the role or the process, or if you want advice on your specific situation, feel free to contact Carl Lens at +31(0)20 462 30 60.

For more information about ViCentra, please visit www.hellokaleido.com