There are jobs and there are careers. The chance to do that kind of work that adds up to something meaningful. The opportunity to challenge yourself and learn new skills. The prospect of being surrounded by smart, ambitious, motivated people with an entrepreneurial spirit, day-in and day-out.
Join our team in Eindhoven to help reshape the remote patient monitoring landscape and make products that reach over millions of patients and medical professionals worldwide.
If you’re interested in a career at Inicare but there are no open positions in our jobs listing that apply to you, do not hesitate and contact us anyway. We are always on the lookout for talented people with an entrepreneurial mindset.
Currently open positions
We are looking for a Quality specialist, experienced in the field of Medical Devices, to join our company and fulfill the role of Quality Manager. There is opportunity to grow into the role of QA/RA Manager.
- Assure the quality and safety of innovative medical products by implementing a full Quality Management System (QMS) suitable for medical device development, starting with a light-weight framework and expanding it over time.
- Provide the Quality corner stones that are required to support regulatory submissions of our products to both Notified Bodies and the FDA.
- Maintain a Quality Management System, in conformance with FDA and ISO 13485:2016 Design Controls, through the integration of internal and external/medical device industry best practices.
- Measuring Key Performance Indicators. This includes defining, measuring, analyzing KPIs, used in product and process improvement.
- Review & Approval Activities. This includes design verification and validation documentation.
- Inspection & Acceptance Activities. This includes acceptance of supplier deliverables.
- Risk Manager. Lead and participate in risk management sessions.
- Training Coordinator. Coordination, administration and evaluation of training for personnel.
- Design Controls. Guide the product development process and associated verification and validation activities.
- Document Controls. Supporting role for document control in product development.
- A completed university degree.
- A minimum of 5 years of full-time ‘hands-on’ work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research) including at least 3 years of Quality experience e.g. working within a certified QMS such as ISO 13485 and FDA.
- Fluency with (new) EU directives/regulation, guidelines and FDA regulations;
- Demonstrable experience in writing Quality Policies and Procedures and composing technical files/regulatory dossiers suitable for regulatory submissions.
- Confident, able to communicate and collaborate with all levels within the company;
- Able to assimilate, articulate and present information at a high level;
- Excellent interpersonal skills as well as strong verbal communication and report writing skills.
We are not looking for
- acquisition from recruitment agencies