QA Design Control Manager

🌍 Making every move matter

AtViCentra, 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

To support our Quality Engineering team we’re looking out for a QA Design Control Manager. In this role you will lead quality activities across product design, process development, and technology implementation. You ensure that ViCentra’s design control, verification & validation, and design transfer processes meet global regulatory requirements and internal quality standards. You will guide the team in embedding a strong quality mindset, supporting robust product development, and enabling the company's continued scaleup. As we're a fast pacing and a highly regulated environment, we’re looking for a motivated self‑starter who’s happy to take ownership and isn’t afraid to jump in when problems come up. You’ll spot issues, speak up, and help find practical solutions. In return, you'll get to work in a place where your efforts really make a difference and where you’ll play an important role in moving our Kaleido product line forward.

🔧 What you’ll take on

• Lead design control activities across design input, design output, verification, validation, transfer, and change management.

• Ensure documentation, methods, and processes comply with ISO 13485, EU MDR, 21 CFR 820, and internal standards.

• Guide and develop Quality Engineers, including junior team members.

• Allocate resources and support delivery of key product and process development milestones.

• Support continuous improvement across QMS-driven activities (CAPA, nonconformance, training, improvement projects).

• Contribute to building scalable quality processes suited for a growing organisation and dynamic environment.

📌 What you bring

• At least a bachelor's degree in quality, Mechanical, or Biomedical Engineering; Health Sciences; or equivalent practical experience.
• Minimum 5–7 years of Quality Engineering experience, ideally within medical devices or a strongly regulated industry.
• Excellent understanding of ISO 13485, EU MDR, 21 CFR 820.
• Strong understanding of Design Control processes and phases, including V&V activities such as DV testing, usability, biocompatibility/biosafety, IEC 60601 testing, shipment & shelflife testing, etc.
• Deep knowledge of QMS principles, CAPA, risk management, and nonconformance processes.
• Experience acting as a team lead or junior manager (2–3+ years), or clear readiness for a managerial step.
• Comfortable working in a scaleup environment with evolving processes and high change velocity.
• Fluent in written and spoken English.

💡 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.

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