QA/IS Specialist

About Aidence

At Aidence, we rally 90+ of the brightest data scientists, software engineers, medical, regulatory, and commercial experts, all driven by the purpose of drastically improving medical diagnostics using AI.

Aidence is part of RadNet’s Artificial Intelligence division. In seven years of activity, we built a solid track record of deployments and gained the trust of physicians who recognise the problem we are solving for them. Our solution, focusing on early lung cancer diagnosis, is currently used in screening programmes and routine clinical practice across Europe.

We have become the strong company we are today because our team represents a wide variety of cultures and backgrounds. We believe that our differences complement each other and, by actively promoting inclusion at all levels throughout our organisation, we offer equal chances to everyone.

Are you a team player, humble, energetic, and passionate about our mission? Do you want to be part of a fast-growing scale-up that is making a difference in healthcare?

 

Then please continue reading!

 

Core responsibilities

• Work cross-functionally to establish, maintain, implement and continuously improve Quality and Information Security processes; including but not limited to customer feedback, CAPA management, and configuration management;

• Work with Regulatory Agencies (as appropriate), including but not limited to Certification bodies, EU Competent Authorities and US FDA;

• Manage, organise and/or conduct internal audits and participate in external audits;

• Lead the site Quality and Information Security Management System training (and retraining) to ensure compliance with ISO 27001, ISO 13485, MDSAP, MDR and Quality System Regulations (US);

• Assist in the evaluation and qualification of suppliers;

• Promote awareness of Quality and Information Security requirements throughout the site;

• Monitor and report on the effectiveness of the QMS / ISMS to management, and identify risks with regards to the effectiveness of the QMS / ISMS in a timely manner;

• Identify opportunities for improvement in the QMS / ISMS, prepare and implement quality improvement plans;

• Identify, analyse and implement QMS / ISMS regulations and standards required to enter into new territories (e.g. United States, Canada, Brazil, Australia, Japan) as directed.

What we value:

• You have at least 3-5 years of practical working experience in a highly regulated QMS and /or ISMS environment;

• A self-starting mentality, meaning you are capable of identifying weaknesses and threats to ISMS / QMS compliance, bringing those forward to management and relevant stakeholders, and push for implementation of improvements;

• You hold a Bachelor's degree or similar in a relevant field of expertise, or have sufficient working experience;

• You have strong verbal and written communication skills in the English language;

• You have good understanding and practical experience with Medical Device Regulations (preferably EU and US);

• You are knowledgeable and preferably experienced in working with ISO 13485, 21 CFR 820, & MDSAP and/or ISO 27001;

• You motivate and drive people within a high performing organisation;

• You are capable of analysing a root cause of a problem and formulate a solution to prevent recurrence of a problem;

• You are committed to set up clear rules and have others adhere to them;

• You enjoy working in an ethical, principled, and are willing to do what is right;

• You possess the strength to make, and stand by, difficult and possibly unpopular decisions;

• You anticipate breaches of the ISMS / QMS and react in a timely and effective manner to unforeseen complications.

The position reports to the Head of Regulatory Compliance

What we offer

• A chance to have a real impact on the fight against cancer!

• Salary range: 60-70k/yr

• We have a remote first policy and offer flexible working locations, but for this role you are preferable based in The Netherlands.

• 25 vacation days (on a full time basis.)

• Lots of autonomy, lots of responsibility.

• Very smart, passionate colleagues.

Interview Process

Our selection process has the following interview stages:

• Introductory phone interview with Recruitment (45min)

• Interview with the Hiring Manager & HR (45min)

• A business case exercise followed by an interview in which we will go through your exercise (~1.5h).

• Final interview with Manager from one of our affiliates we closely work with (~1h)

• Each interview will give you plenty of time to ask questions to your future team.

 

Our philosophy is that we respect the time of our candidates, we won’t ask you to do an interview just for show, we won’t make you wait indefinitely and we will always give you feedback. We want to make a decision (either successful or not) in a matter of a couple of weeks, better if less.

 

Acquisition to this vacancy is not appreciated