Orikami is in transition to being a fully MDR compliant manufacturer of software medical devices. As a RA/QA manager your QA role is to oversee and contribute to the development of the Orikami QMS. Together with external quality experts, you will assist Orikami employees in capturing their work in practical and compliant procedures and templates.
Your responsibilities include developing and conducting quality training programs and ensuring the QMS is properly implemented and embedded in the Orikami organisation. In your QA role you will assure that the QMS is used, maintained and improved (where possible).
In your RA role you need to ensure that Orikami medical devices meet the regulatory requirements. You will be responsible for product registrations, regulatory compliance of technical documentation and making sure post-market surveillance and vigilance activities are executed in line with the QMS.
- Develop, implement and continuously improve the QMS and ensure compliance to regulatory requirements.
- Ensure that all employees involved in quality do receive appropriate training as required by the QMS.
- Assist employees in the development and implementation of the necessary quality related procedures and training.
- Perform internal audits and organise management reviews.
- Provide input to the development team and management on applicable regulations and standards.
- Review and approve technical documentation.
- Product registrations
- Communication with notified bodies and reporting to competent authorities related to Orikami products and activities.
Profile & background
Firstly, we think it is very important that you fit well into our team. Your motivation shows that you have a curious attitude, you are authentic, believe in craftsmanship and dare to think differently with your vision on quality and regulatory compliance in the healthcare sector.
- 4 years experience in a RA or QA role in medical devices (ISO 13485)
- 1 year experience as a RA or QA manager
- Knowledge of MDR and ISO 13485
- Project management skills
- Experience in stakeholder management
Nice to have
- Experience with MDR certification
- Experience with Software medical device development (IEC 62304)
Among highly skilled colleagues, you are welcome in our ambitious and innovative working place. On top of that, we offer:
- An ambitious and innovative working place
- Highly skilled colleagues
- Market-conform salary with attractive bonus scheme
- 25 vacation days with full-time employment
- Excellent training and development opportunities with dedicated learning time
- Freedom to organize your work according to your own wishes and needs
- Good work / life balance and the ability to work 80%
- Stock programme, SAR
- Attractive collective pension scheme
- An inspiring and stimulating work environment with enthusiastic and committed colleagues, with plenty of room for informal activities
Orikami is a Dutch MedTech organization specialized in applied data science and development and implementation of digital biomarkers to enable personalized healthcare for people with chronic diseases.
With a team of data scientists and researchers we are on a mission to improve 100 million lives before 2030 by access to personalized healthcare. We believe health data is underutilized. We use real world patient data to enable personalized healthcare paths for our clients to improve outcomes, quality of life and affordable healthcare.
Therefore we develop digital biomarkers: Software as Medical Device used by patients and clinicians to collect, analyse and report on objective outcomes that improve a patient’s life. For example, we use the smartphone acceleration and GPS to calculate the walking distance in a clinically validated 2-Minute Walking Test (2MWT).
How to apply
Are you motivated to work with us? We would like to meet you! Send your application to Marianne Mathijssen, HR manager before 15th May 2021 with motivation and CV.
For more information you can call +31 (0)6-45227854 or visit our webpage www.orikami.nl