QA/RA manager

full-time / part-time
Location: FastFocus headquarters in Harmelen, Utrecht


About FastFocus

FastFocus started as an internal research team of Agis Automatisering. The company has been developing high-tech sensor technology for various markets since 1984. Since 2013, we are an independent company and we develop innovative e-health solutions for the healthcare market.

Currently, we are finalizing the certification of a medical device system that enables monitoring of multiple physiologic parameters on ambulant patients. The system offers a flexible solution for hospitals, it enables new healthcare possibilities and improves patient safety.

Our team
Our team consists of skilled and motivated professionals. We work with several renowned institutes; such as hospitals, academies and high-tech companies. This provides us with the possibility to combine the best technology with the latest expertise from across many fields.

You will play a connecting role between the different disciplines of the team. We work hard, but there is time and space to make small talk. The involvement towards each other is great. The beautiful surroundings invite you to get some fresh air in the afternoon break. We enjoy our annual company outing, monthly drink and other team events.

The position
FastFocus have a current opportunity for a QA/RA manager to join our innovative and ambitious team. As a QA/RA Manager, you will be the authority for all quality assurance aspects and regulatory affairs.


Tasks and responsibilities
  • Define the strategic impact of regulatory and quality choices in relation with product development process
  • Formulate the main objectives and activities for certification and marking
  • Formulate risk management policies and activities
  • Report on the progress of realizing the plans and take actions to stay on target
  • Lead to cooperation-oriented way of working which results in establishing and realizing the strategy of FastFocus
  • Have regular contacts with notified bodies and report substantial changes to the notified body
  • Manage the Quality Management System
  • Report on the way of working of FastFocus in relation to the QMS as internal audits
  • Act as the GDPR-responsible within FastFocus
  • Responsible for all needed technical file documents


Who are we looking for?
To be successful in this role, you are a natural problem solver with strong analytical skills and a pro-active, hands-on mentality. You have a drive for quality and results with a clear focus on customer safety and continuous improvement. You are a team player, who’s able to build lasting relations with colleagues across departments and disciplines. You can work under pressure, managing several tasks and projects at once poses no problem for you.


Qualifications and experience
  • Academic degree in Medical Devices, Medical Devices Regulatory or alike
  • At least three years of experience in a similar role
  • Knowledge of:
    o MDD and MDR
    o ISO 13485
    o ISO 14971
    o IEC 60601-1
  • Knowledge and experience with corrective action and preventive action system, release test statistical sampling methods, quality risk management, FMEA and other key tools for managing quality performance

Abilities
  • Able to collect, organize, analyse, and disseminate significant amounts of information with attention to detail and accuracy
  • Solution focussed with a high level of self-motivation, drive and tenacity
  • Strong admin and IT skills
  • Adept at queries, report writing and presenting findings
  • Confidence working in a fast-paced environment
  • Fluent in English, both oral and written and ideally have a good level of Dutch.
  • Good communication skills
  • Exceptional attention to detail
  • Ability to work independently and prioritise work


What do we offer?
In addition to working on a ground-breaking new product, you’ll be working in a small, friendly and motivated team; all ideas are welcome, and great work is rewarded. We’re offering:

  • An interesting job in an innovative company
  • A family culture with an informal and personal atmosphere
  • A unique rural working environment in the Utrecht region
  • Enthusiastic, involved and pleasant colleagues
  • Independence and a high degree of responsibleness
  • Contribute to the growth strategy of the organization and to your own
  • Fresh fruit
  • A competitive salary
  • Assistance for 30% ruling application if applicable
  • Contribution towards commuting costs
  • Free on-site parking
  • A large contribution to your pension
  • A company laptop.
  • A work environment where you can develop your skills, learn from the best and where we rewarded for your creativity



If this vacancy appeals to you and if you meet the profile described, we would like to meet you! Interested? Are you interested in the above function or do you have any questions? You can call 0348-443840 (Ron van Oudenallen) or send your letter of application and your C.V. to solliciteren@fastfocus.nl.

Due to the international nature of FastFocus applications shall be in English. Candidates must have the right to work in the Netherlands.

Acquisition as a result of this advertisement is NOT appreciated.