Quality Assurance and Information Security Associate

Job description

Quality assurance and information security are vital

The last 10 years the importance of QA and IS has rapidly increased. Being an innovative company
delivering technology to healthcare and hospitals these domains are not only important but vital. For the outside world this is proven by all kinds of certifications but for everyone at Aidence QA and IS are
of the essence 24x7. Due to the innovative character of our product, we are working in uncharted regulatory territories, which makes working in QA/RA/IS at Aidence a real challenge.

Because our aim is growth in all kind of ways (areas, geographies, people etc.) we must expand our Quality Affairs (QA), Information Security (IS) and Regulatory (RA) team. That’s why we are looking for
a QA/IS associate .


Tasks and Responsibilities
● Establish, maintain and continuously improves QMS / IS and processes required by
international regulatory authorities and standards
● Work closely with Certification bodies and Competent Authorities
● Organise and/or conduct internal audits and host external audits
● Train the wider team on the application of quality and information security objectives
● Ensure promotion of awareness of regulatory, customer, QMS / IS requirements throughout the
organization
● Monitor and report on Quality and Security Objectives related to QMS / IS

Requirements

● Minimum of 3 years experience with QA and/or IS

● Higher education (University)
● Understanding and practical experience of EU & USA Medical Device Regulations
● Knowledge and experience working with at least ISO 13485 or 27001 and preferably ISO 14971
● Ability to perform effectively in complex and difficult environments
● Ability to think of bigger picture with a strong focus on details
● Execution thorough and diligent
● Ability to think about all the factors that might affect a situation
● Ability to analyse root cause of a problem and formulate a solution for recurrence of the
problem
● Committed to set up clear rules and have others adhere to them
● Ethical, principled, and willing to do what is right
● Possess the strength to make, and stand by, difficult and possibly unpopular decisions.
● Anticipate breaches of regulations and react in a timely and effective manner to unforeseen
complications
● Fun to work with

Our promise
● Challenging position in a growing and ambitious company
● An environment to grow and learn both professional and personal
● All joys and burdens of a scale up
● Highly motivated and inspiring colleagues
● Very competitive remuneration package
● A brand new office with a great Amstel Hotel view…


Interested or questions
Please send an email to Walter Doorduin (+31 6 300 78 316 - walter[at]aidence.com) or send us your
application through our website. We will respond within 5 days.