Quality Manager – Ivy Medical

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Quality Manager

Ivy Medical is looking for an experienced Quality Manager

Ivy Medical is creating a next-generation infusion pump to reinvent the experience of infusion therapy for patients and medical professionals. Forget the infusion pole: Ivy’s wearable recovery pump allows patients to receive IV therapy safely and uninterruptedly while roaming freely in the hospital. Ivy’s patented technology allows nurses to make a treatment plan for the whole day, lowering the workload and reducing stress. The Ivy Duo+ is an innovative Medical Device (class IIb) with a unique disposable that will revolutionize infusion therapy as we know it today.

Are you passionate about Quality Management (ISO 13485) and Innovative Medical Devices?

Apply now!

Job Description

We are looking for a Quality Manager who is passionate about making a difference in the lives of patients and nurses. As a Quality Manager, you will be responsible for maintaining and improving our Quality Management System (QMS) to ensure compliance with MDR, ISO 13485 and other applicable standards. The ideal candidate will have a hands-on mentality, pragmatic way of working, and experience with MDR and ISO 13485. At Ivy Medical, our core values are Excitement, Ownership, and Quality, and our mission is to reinvent the experience of infusion therapy for patients and nurses. We are searching for someone who wants to use their skills and experience to take this step with us and help us outline a clear and structured system towards market launch and beyond.

Responsibilities:

As a Quality Manager at Ivy Medical, you are a crucial player in the organization. We are looking for someone who wants to put their skills and experience to use and help Ivy Medical take things to the next levels. You will be responsible for:

Develop, implement, and maintain the QMS to ensure compliance with ISO 13485 and other applicable standards.
Implement and maintain quality control processes, including inspection and testing procedures.
Contribute to ensure the quality management system and good documentation practices are met.
Contribute to complaint handling, CAPA’s, document and record control, data collection and analysis, project management, internal and external audits, and reporting changes to a notified body.
Collaborate with team members from different disciplines to ensure quality objectives are met.
Drive continuous improvement initiatives to optimize quality processes and reduce costs.
Provide training and support to employees on quality-related matters.
Embody Ivy Medical’s core values of Excitement, Ownership, and Quality in all aspects of the job.

Not your responsibilities:

Conduct risk management activities and lead the development of risk management files.
Clinical evaluation activities and content-related design and development activities.

Requirements:

Bachelor’s degree in a relevant field.
A minimum of 3 years of experience in Quality Management, preferably in the medical device industry.
Knowledge of the Medical Device Regulation (MDR).
Strong knowledge and experience with ISO 13485.
Experience leading and supporting internal and external audits.
Excellent communication, leadership, and problem-solving skills.
Ability to work independently and as part of a team.
Hands-on mentality and pragmatic way of working.
Highly proficient in spoken and written English and Dutch.
Possessing the following competences
- Exceptional eye for detail;
- Planning skills;
- Decisive;
- Ability to set the correct priorities;
- Managing several priorities simultaneously.

In return, we offer you

We welcome you to a challenging, innovative environment with the opportunity to make a significant impact in healthcare. In addition to working on a groundbreaking new product, you’ll be working in a small, friendly, and highly motivated team; all ideas are welcome and great work is rewarded. Moreover, we have a creative and informal office vibe and we believe in creating a fun and exciting work environment. Team lunches, Friday afternoon drinks, and outings are just some examples.

We also offer:

A competitive salary
Flexible holiday days
Opportunities for personal and professional growth
A culture of freedom and responsibility
The chance to be a part of a company that is reinventing the experience of infusion therapy for patients and nurses.

Even More: Groningen!

You will be working on-site in one of the most innovative cities of the Netherlands, with a beautiful city center. Providing a vibrant, creative, and international environment, it is the largest city in the North. And not unimportantly: the healthiest city in the Netherlands

Apply today

Please e-mail your CV and motivation as soon as possible to HR@ivymedical.nl. We will respond to you the next workday and provide you insight into our recruitment process. If you have any queries, feel free to call +31 (0) 50 211 57 76.

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