(Senior) Quality Engineer - Design Assurance and Risk Management

🌍 Making every move matter

At ViCentra, we’re on a mission to redefine what’s possible in diabetes care. 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 a (Senior) Quality Engineer – Design Assurance & Risk Management, you’ll ensure our products exceed the highest standards of quality, safety, and risk control. Your expertise will be central to every stage of product development, making you a driving force behind our mission to make life easier for people with diabetes.

You’ll take ownership of design quality and risk management across development, manufacturing, and post-market phases. Acting as a trusted partner to R&D, Manufacturing, Product Management, and Regulatory Affairs, you’ll help shape products and processes that truly make a difference.

We’re a fast-paced and highly regulated environment, so 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

In your role, you will:

• Ensure robust design quality and compliance from development through design transfer (hardware and software), collaborating closely with R&D.

• Support creating and maintaining Risk Management Files aligned with ISO 14971, EU MDR, and FDA requirements, covering design, production, and post-market phases.

• Partner with Manufacturing, R&D, Quality, Regulatory, suppliers, and CMOs to develop and improve quality controls and documentation.

• Work closely with R&D to establish system design requirements, specifications, and verification & validation activities; actively support and engage in design reviews.

• Lead and participate in risk analysis and control sessions, ensuring risks are identified, documented, and mitigated effectively.

• Support change control activities related to design, development, and manufacturing changes.

• Deliver quality-related training and support internal, supplier, and external audits.

• Maintain compliance with applicable regulations (ISO 13485, ISO 14971, EU MDR, 21 CFR 820) and internal standards.

• Deliver lasting impact: Your work won’t just support individual projects—you’ll help raise the bar for quality and risk management across our entire organization.
  
  

📌 What you bring

• A bachelor’s degree in Quality, Mechanical/Biomedical Engineering, Health Sciences, or equivalent practical experience.

• At least 5 years of proven experience in Quality Engineering within a regulated industry (medical devices preferred).

• Strong understanding of Design Control processes and phases, including V&V activities like DV testing, usability, shipment & shelf-life testing, IEC 60601, biosafety, etc.

• Deep knowledge of risk management principles, quality control, QMS, CAPA, and non-conformance processes.

• Excellent grasp of relevant regulations: ISO 13485, ISO 14971, EU MDR, and 21 CFR 820.

• High proficiency in Microsoft Office and solid general IT skills.

• Fluent written and spoken English.

 
Bonus points: 

• Experience in a start-up or scale-up environment. 

• Familiarity with cleanroom standards and/or sterilization processes (Gamma, EtO). 

• Experience with Minitab or similar data analysis/statistics softwar 

• Experience in Process validation (IQ/OQ/PQ) 

💡 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, fuelled by curiosity, diverse perspectives, and a love for collaboration. Here, you can shape and be shaped by ground breaking 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.