ViCentra · Utrecht, Utrecht, Netherlands
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Posted 14 days ago
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📣 Join ViCentra – Empower Bold Change in MedTech
📍 Location: Utrecht
💼 Hybrid or On-site
🌍 Making Every Move Matter
At ViCentra, we’re on a mission to make living with diabetes easier, by designing simple, beautiful, and effective solutions that fit people’s lives, not the other way around. We combine technological innovation with human-centered design to empower people with more freedom, confidence, and life on their terms. Our values; Be Bold, Build Trust, Focus on the Customer and Deliver Excellence drive everything we create and every decision we make.
We believe that when ambition meets purpose, remarkable things happen. If you thrive in a space where ideas accelerate, challenges spark growth, and making a difference is the goal, ViCentra is your next great adventure. 🚀
👩💻 Your Impact
As Quality Specialist – QMS, you take ownership of the end‑to‑end company process landscape and drive continuous improvement across all functions. You bring structure where workflows are fragmented, translating them into clear, compliant, and efficient process flows. By introducing meaningful metrics, dashboards, and structured reviews, you create transparency and control, enabling the organization to scale without adding unnecessary complexity or headcount.
Within six months, complexity has been replaced by clarity. Teams understand their processes and responsibilities, leadership has actionable insight, and the QMS actively supports decision‑making rather than slowing it down. You also guide ViCentra toward the next generation of QMS execution, where AI supports procedure maintenance, cross‑referencing, and regulatory alignment, ensuring processes and procedures remain correctly connected as the organization evolves.
In essence, your impact is making quality scalable, intelligent, and embedded in how ViCentra works.
🔧 What You’ll Take On
In your role, you will:
Take ownership of continuous improvement across all business processes, not limited to QA‑owned processes
Guide teams in mapping, structuring, and documenting their processes in compliant process flows
Advise stakeholders on process design, effectiveness, and regulatory alignment
Oversee and coordinate key QMS processes (e.g. Change Control, CAPA, Data Review)
Lead the monthly collection, review, and analysis of quality metrics
Act as a central point of control within the QMS “cockpit”, ensuring oversight and consistency
Support internal and external audits and perform independent internal audits
Drive the application of AI within QMS execution, such as:
Comparing legacy and new procedures
Checking alignment with regulatory requirements
Ensuring correct links between related procedures, records, and processes
📌 What You Bring
A Bachelor's degree in Engineering, Life Sciences, or similar (Master's a plus)
5+ years in medical devices, with strong command of ISO 13485, 21 CFR 820, and MDR
Solid experience in QMS and process ownership within MedTech or Pharma
Proven ability to look across departments and connect processes end‑to‑end
Experience working with eQMS systems, metrics, and dashboards
Comfortable advising stakeholders and challenging existing ways of working
Structured, analytical, and able to translate complexity into clarity
Interest in digitalization and AI applications within quality systems
Start-up or scale-up experience welcome
💡 Life at ViCentra
Working at ViCentra means joining a team defined by:
Courage to create: We experiment, challenge norms, and learn fast.
Trust above all: Integrity, honesty, and openness shape our relationships.
Customer-first mindset: Every idea is measured by the impact on those we serve.
A drive for excellence: We hold ourselves to the highest standard because lives depend on it.
Our days move fast, fueled by curiosity, diverse perspectives, and a love for collaboration. Here, you can shape and be shaped by groundbreaking work in MedTech.
🌱 Grow With Purpose
Harness your talent for a mission that truly matters.
Enjoy creative freedom, supportive teamwork, and room to lead initiatives.
Make a direct impact in people’s lives, today and into the future.
Be surrounded by innovators who challenge and cheer you on.
🌏 Every Journey Starts Somewhere — Make Yours Count Here
We believe a powerful team is built on unique backgrounds and points of view. If this opportunity excites you but you’re unsure if you fit every bullet, we want to hear your story. At ViCentra, it’s your potential and passion that catch our eye.