QA Specialist - QMS

📣 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Within six months, complexity has been replaced by clarity.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.