Quality Assurance and Regulatory Affairs Manager
Vilje Bionics is a technology start-up that develops a motorized exoskeleton to help people with impaired function in their arms and hands. Many people currently experience reduced quality of life because of impairment or paralysis in their arm or hands and have no suitable aids to compensate for the loss of function. Vilje Bionics intends to do something about this! Our exoskeleton gives back the opportunity to perform everyday activities, giving people with a disability the independence to do what they love.
We are committed to delivering a safe, high-quality medical device. You will be responsible for developing and maintaining the processes we need to ensure the quality and safety of the product. You will set quality goals for the company and be central in developing the regulatory strategy of Vilje Bionics. One of our major goals over the next few years is to achieve a CE certification for our product. As a quality manager, you will gain an understanding of which standards the company and product must comply with. You will investigate and define regulatory requirements for the product in the different phases of development and launch, and map the documentation required for a CE certification. You will together with the technical team develop the procedures and documentation needed and are responsible for the training in these procedures. The work processes in the company shall comply with ISO 13485, and through development and documentation of the processes, you are responsible for building up our quality system, to comply with this standard, among others.
You will lead the quality work in the company in the period leading up to product launch, including taking part in the planning phase of user tests, managing risk assessments according to ISO 14971, and ensuring that trials are carried out in compliance with these assessments. You will also lead the quality assurance work in the design and development processes. After product launch, you will work on quality assurance in manufacturing, maintenance, and continuous improvement of the processes in the company, post-market surveillance of the product, compliance with non-European regulatory requirements (e.g. FDA approval in the US), and development of new products.
Vilje Bionics is a young company, which has just begun work on quality assurance. Through your role as Quality Assurance and Regulatory Affairs Manager, you will shape the culture of quality in the company. You will have a significant influence on the company's strategy, technology, and business development. By working closely with colleagues, mentors, and consultants you will receive support in your responsibilities and tasks.
Your responsibilities will include:
Developing the regulatory strategy for Vilje Bionics and setting quality goals for the company and product
Planning and carrying out the regulatory path towards CE marking (and FDA approval) of our product
Developing and managing a quality management system according to ISO 13485 and working towards an ISO 13485 certification of the company
Developing and improving the processes that ensure efficient work in the company while achieving our quality goals
Creating and maintaining the Standard Operating Procedures (SOP) for the company
Being responsible for internal/external audits
Conducting Risk management for product development, testing, and manufacturing
Keeping track of important standards for Vilje Bionics and delegating work packages to ensure compliance
Ensuring continuous improvement of work processes
Training employees in quality procedures
You must have a higher education degree (MSc/BSc) in engineering, law, health economics, health science, or another relevant scientific discipline. Experience with quality work is a considerable advantage, but it is not required. We will ensure that you receive adequate training through courses and consultants. Learning and development will be a key part of the job.
We are looking for a colleague who is interested in medical technology and wants to work in a company where your job makes a difference in other people's lives. We are looking for you who are:
Structured and thorough: You like to systematize information in a way that you, your colleagues, and externals understand. You have an eye for details and are concerned with the quality of your work.
Engaged: You commit to the company’s vision and mission and want to make an extra effort for the team’s success.
A team player: You can work with others to find exciting opportunities and good solutions. You contribute where it's needed, help everyone work better, are not afraid to speak up about issues, and want to become a better team player yourself.
Independent and a problem solver: You dare to take on a challenge, are not afraid to embark on tasks you have never done before, and are not afraid to fail. You can quickly familiarize yourself with how to do things. You will find your tasks and seek help from colleagues and externals when needed.
Proficient in writing in English: You communicate and write neatly in English. It is an advantage if you also can speak and write in Norwegian, but it is not required.
An exciting and incredibly meaningful permanent job in social offices at Aleap in Oslo Science Park.
Flexible working hours, competitive salary, and the possibility of becoming a shareholder in the company.
A unique opportunity to join the growth of an innovative start-up at an early stage.
Motivating and varying tasks, freedom, and responsibility in your work from the first day
Work in a business where you get to see the value of your contributions right away. A business that is small enough for your contribution to be making a big difference but established enough to give you the tools you need.
Build a large network within medical technology and entrepreneurship through colleagues, start-ups, and established companies, partners, and mentors.
An engaging, innovative, and social working environment facilitating work/life balance.
The opportunity to learn and become a certified quality manager.
An application text describing why you want to work in Vilje Bionics
CV
Diploma/transcript of grades from higher education
Starting date for graduates: Flexible start part-time after the new year 2022 and full-time from August 2022. Starting date for professionals: Flexible start full-time after the new year 2022 Application, CV, and records must be sent to post@viljebionics.com
Application Deadline: 14.11.21
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