Operational Excellence Manager

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Are you a believer in the power of processes and efficiency? Do you have a talent in turning entropy into structure? We need you! Visiba Care is looking for our first Operational Excellence Manager to support our entire organisation in outlining and maintaining our quality standards.

What can you expect in the role?
You will be the first Operational Excellence Manager at Visiba, which means you will have the opportunity to bring your previous experience and use all your creativity to form your position. This also means the role will develop with our growth. The placement is at the Visiba headquarters in Gothenburg.

Some of your day-to-day tasks will most likely include: 

  • Being responsible for our quality management system for medical devices 
  • Reporting to management on quality-related matters
  • Support colleagues in stakeholder meetings when your expertise is needed
  • Perform risk analyzes according to 14971
  • Following up on the quality objectives
  • Supplier evaluation
  • Run improvement projects
  • Being responsible for audits, both externally and internally
  • Being the contact person for authorities/notified bodies (FSN, MIR etc)
  • Being responsible for noncomformities and CAPA
  • Educate your colleagues in quality management system
  • Monitor, maintain and control the quality system according to ISO 13485, MDR and other relevant standards
  • Write, review, and approve documentation and projects regarding standards and regulations
  • Analyze the needs, improve upon and support in the implementation of cross-functional processes to ensure operational excellence

 

Who you are 
To thrive in this role, you need to be self-propelled with an interest in bringing value towards customers and end-users. You do not hesitate to think outside the box and you focus on solutions instead of problems. You believe that the best results come from collaboration and it is easy for you to reach out and communicate with others to create understanding of your point of view. You have an outspoken ‘get things done’ personality and taking initiatives comes naturally to you.

Requirements:

  • Excellent English skills, both written and spoken
  • Probably 3-4 years of professional experience in regulatory affairs or in quality management systems related to medical devices
  • Knowledge within ISO13485
  • Basic knowledge of risk management/risk analysis according to ISO 14971
  • Knowledge within EN 62304 Software life cycle for medical devices
  • Diploma, certificate (or other formal qualification) from a university in law, medicine, pharmacy, engineering or other relevant scientific discipline
  • Experience in regulatory affairs or in quality management systems related to medical devices
  • You are a natural in building trust and make complicated information easy to understand

It is good if you have experience from one or several below: 

  • Experience working in a SaaS company
  • Experience working with medical software
  • Relevant university degree according to MDR
  • Experience working in healthcare or any related area, like Pharma or MedTech 

Who will help you succeed? 
At Visiba Care we believe in the individual’s ability to lead themselves, and as leaders we share the philosophy of freedom with responsibility. As part of our team you will have me, Johan, as your direct manager. I’m the CEO at Visiba and a strong believer in self-leadership and that you are the expert in your area. When I’m not at work, you will find me working out one way or the other or supporting my kids wrestling club. Even though we encourage individual achievements at Visiba Care, we believe that, without great teamwork, we will never be able to change healthcare at its core. We achieve great things by supporting and challenging each other, and not least by having fun together!

What we offer

  • We offer the possibility to be part of a journey to change the world by improving healthcare with new innovative products 
  • An amazing workplace at Visiba Care’s headquarters in Gothenburg*  
  • A challenging environment where we will guarantee that you will grow 
  • Phone and computer
  • Free training with a PT every Friday* 
  • 30 days paid leave 
  • Competitive salary and pension program 
  • Full pay during parental leave 
  • …and a lot more!  

 *All available when it is again possible.
 
This is a full-time, permanent position based in Gothenburg. We are reviewing applications on a rolling basis so don’t hesitate to apply right away! While the start date is flexible, the right candidate can join us immediately. If you have any further questions please contact Talent Acquisition Partner: felicia.hartvig@visibacare.com or +46707134128. 

About Visiba Care 
Visiba Care is a cloud-based software solution that enables healthcare providers to get started with their own branded digital practice. Founded as a purpose-driven company in 2014, Visiba Care's mission is to empower healthcare providers and improve people's lives. Visiba Care leads the market for digital healthcare consultations in Sweden, and is advancing in other markets such as Norway, Finland and the UK. The customers vary in range, from smaller clinics to large healthcare organisations, both in to public and private sector. Visiba Care's headquarter is located in Gothenburg, Sweden. Visit us at www.visibacare.com

Or, know someone who would be a perfect fit? Let them know!

Göteborg

Krokslätts Fabriker 61
431 37 Mölndal Directions View page

Our values

  • We care

    for each other, by being warm, attentive and respectful

    for our customers by going the extra mile to help them succeed

    for the society by contributing to a healthy and sustainable world

  • We act

    with passion and curiosity to accomplish great things

    with a pragmatic mindset, focused on getting things done

    by celebrating each other's achievements and having fun

  • We grow

    as individuals by challenging and supporting each other

    as a team by sharing knowledge and aligning our goals

    as a company by aiming high, driving and embracing change

Workplace & Culture

We believe that individuality strengthens our team, and that striving towards a common goal doesn't require conformity. At Visiba Care you are encouraged to find your own way and rely on your own creativity. Together we will discover the unique way in which you and only you can contribute to our work. Our growth and expansion across Europe brings new and fun challenges every day. It also brings new opportunities for you to grow as an individual and professional.

And if you're a musician, a gamer or a hobby politician, or if you collect breakfast cereals(!), well then you'll find friends of like mind in our family. No one said changing the world couldn't be fun!

Already working at Visiba Care?

Let’s recruit together and find your next colleague.

email
@visibacare.com
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