Quality Manager

Are you experienced in Quality Assurance (QA) and Quality Control (QC) for medical products? Do you want to be part of a dynamic, fast-growing company where you can make a real difference? Vivolta is looking for a passionate Quality Manager to join our team!

As a key member of our organization, you’ll be responsible for ensuring the efficient implementation of the quality management system (QMS). In this challenging and diverse role, you’ll collaborate across departments to drive improvements, uphold high standards, and promote a culture of excellence.

What will you get to do in this challenging position?
Vivolta uses in-house developed knowledge, tooling, and production machines for electrospinning. As Quality Manager, you’ll oversee several critical areas:

• Support & Improve Quality Systems: Review and enhance quality system processes to improve awareness and communication across the company and to ensure that the quality system is effectively applied at all levels across the organization.
• Monitor Regulatory Changes: Stay on top of Medical Device Regulations (FDA and EU – MDR) and ensure the Quality Manual and Procedures reflect new requirements from European Directives and regulatory standards.
• Develop and maintain Procedures: Work with management to create, monitor and maintain quality system procedures and ensuring they meet required standards.
• Lead Audits: Prepare for and lead internal and external (notified body) audits, including scheduling, records, and reporting.
• CAPA Tracking: Track and assist in Corrective and Preventive Actions (CAPA) to resolve quality issues and collaborate with suppliers.
• Investigate Complaints: Review customer complaints, investigate root causes of product failures, and assess risk.
• Product Release Authorization: Oversee product release , ensuring all necessary records are completed.
• Manage: Manages the department to completion of the yearly objectives and act as management representative of Vivolta

What we’re looking for?
We’re seeking someone with a keen eye for detail who is eager to help develop groundbreaking medical products that improve people’s lives. If you meet the following qualifications, we’d love to hear from you:

• Experience with Quality Systems: Knowledge of ISO 13485 and medical device regulations (FDA, EU MDR), including relevant standards and guidelines.
• Minimum 5 Years in Quality Management: Proven experience in quality management within a a manufacturing environment
• Relevant Degree: A Bachelor’s degree (HBO/WO) in a relevant field.
• Strong Leadership & Communication: Ability to lead teams and communicate effectively across all levels.
• Fluent in English: Both spoken and written.
• Availability: Able to work 32 to 40 hours per week.
• Bonus Experience: GMP (Good Manufacturing Practice) experience is a plus but not required.

What does Vivolta offer?
We offer a dynamic role in a high-tech, innovative company, where you will be part of groundbreaking projects that shape the future of medicine. Vivolta is an informal, growing company that values its employees, their individual needs, and team spirit. Additional benefits include:

• Attractive Benefits: Competitive pension plan, lease-a-bike possibility and at least 25 vacation days (increasing with age to 30) and 5 ADV days.
• Flexible Hours: A work-life balance that works for you.
• Stock Appreciation Rights (SAR): Access to a SAR scheme.
• Career Growth: Long-term employment prospects and opportunities for professional development through training and courses.
• Collaborative Work Environment: Work with passionate colleagues, excellent equipment, and a culture that encourages teamwork, knowledge sharing, and initiative.

What is medical electrospinning?
In short, it’s where science meets art. We create super-thin polymer fibers used in life-changing medical solutions—think stents, artificial blood vessels, and heart valves. These fibers mimic the natural environment of cells, reducing rejection and scarring, and ultimately help the body heal itself.

About us
We’re a growing MedTech CDMO that’s making waves in the medical world with our innovative implants. Our team of engineers and scientists is at the heart of what we do, and we’re doubling in size to take on even bigger challenges. Want to be part of something groundbreaking? Join us!

Interested?
Reach out to Lianne Valster at +31(0) 40 282 79 56 or to jobs@vivolta.com.

Heads up!
We’re building our dream team directly, so external recruitment agencies—thanks, but no thanks. Also, please note that Vivolta is not a recognized sponsor for visa applications. This means we’re currently only able to consider candidates with a valid EU passport.