Qa Manager vacatures bij Outcome Measurement

VACANCY QUALITY AND COMPLIANCE MANAGER

Do you talk about patient safety at parties, do you know immediately what is meant by a hazard traceability matrix, pFMEA or design verification and how to implement it pragmatically and compliantly, and are you someone who feels at home in a young dynamic scale-up environment. Then we are looking for you!

VACANCY QUALITY AND COMPLIANCE MANAGER

Do you talk about patient safety at parties, do you know immediately what is meant by a hazard traceability matrix, pFMEA or design verification and how to implement it pragmatically and compliantly, and are you someone who feels at home in a young dynamic scale-up environment. Then we are looking for you!

WHO ARE WE

We are ConsultAssistent: an eHealth solution developed by doctors for doctors. It is our miss that from every previous patient we can learn how to improve the care for the next one.

ConsultAssistent is a tool for digital history and follow-up. The adaptive question modules in ConsultAssistent contain many of the questions that are asked by the specialist to the patient during a consultation. With ConsultAssistent, these questions are answered by the patient in advance online. This makes the consultation more effective, consultation productivity higher, patients are better prepared and there are more triage opportunities. Unique data is also collected for scientific research, to learn from and to develop predictive (artificial intelligence) algorithms for decision support.

Every day, we work with great pleasure and considerable drive on a product that demonstrably adds value for patients and healthcare providers. We are a scale-up; our size allows us to innovate quickly and to continuously optimise our product. Geared to the needs of the users. We do this together with our extensive network of customers and cooperation partners.

WHAT YOU ARE GOING TO DO

You will be our safety guru. You will help us improve patient safety even further and help us be and remain compliant with relevant laws and regulations, including the MDR. You will do this by taking ownership of our quality management system (QMS), helping the team to further improve work processes and procedures, and ensuring that our technical documentation is always up-to-date and compliant. This so that we further improve the quality of our product and service and further reduce risks. You will work closely with our Information Security Officer.

You will report directly to management and the board on the effectiveness of our quality management system and opportunities for improvement in it. You improve our employees' awareness of patient safety and compliance with relevant standards. During audits, you will be the contact person for the auditor. You will assume the role of PRRC and potentially FG as well.

Our QMS is in Confluence, as is our ISMS, we use Jira for monitoring controls, Comala for our document management and Riskmanager for managing our risks. The spoken language in the office is Dutch, our QMS and ISMS are in English.

We are a small team, everyone is very committed to safety. There is a nice foundation. Because we are a small team it is important to work pragmatically. And to automate processes wherever possible. A nice challenge to sink your teeth into.

WHO WE ARE SEARCHING

We are looking for a topper with broad quality and compliance experience, someone who has worked in the role of quality manager and/or compliance officer or compliance manager for several years. We have a very strong preference for experience in the medical sector and relevant ISO standards. Working in a startup environment and an agile way of working suits you. You have vision, are entrepreneurial, oversee the big picture but have an eye for detail. You have the drive to improve yourself and our team.

• You have a completed university education and at least 2 years of relevant work experience in the field of quality and/or compliance management or you have at least a completed college education and 5 years of relevant work experience;
• Your relevant work experience preferably gained in the medical field;
• You know and can carry out the responsibilities and authority of a PRRC;
• You have knowledge of the MDR;
• You write and speak fluent Dutch and English;
• You have an eye for the smallest detail and a good view of the big picture. You can easily switch between the two;
• You have a strong personality, you can convince and listen well;
• You have the natural authority within you to speak to government organizations on behalf of our organization;
• You are not averse to getting your feet in the clay and rolling up your sleeves;
• Good knowledge of privacy legislation is a plus, as is knowledge of health care legislation.

WHAT WE OFFER YOU

Are you our new Compliance and Quality Manager and will you be working in an ambitious and instructive startup environment where there is plenty of room for initiative and your own input? We offer a varied job with direct responsibility and plenty of room for entrepreneurship. You have a nice, young team and get the space to organize the work in your own way and shape your own development and that of your team. We also offer you:

• An attractive salary that can increase with bonuses based on personal and company results;
• An interesting training budget;
• NS business card;
• A cool office location in the heart of Rotterdam
• Sociability with drinks parties and company outings, among other things;
• After the first temporary contract, growth to permanent contract.

You will be based in Rotterdam, with an office in the CIC at the Groot Handelsgebouw right next to Central Station. If you are not working at the office, you will often be with our clients, hospitals throughout the Netherlands. Working from home or elsewhere is of course no problem.

ABOUT US

ConsultAssistent is a product of Outcome Measurement BV, which was founded by Henk Blom (ENT specialist), Martijn Buitenhuis (Buitenhuis Advies) and Funatic (specialist in patient portals). By joining forces, a successful collaboration has been created in which extensive knowledge of healthcare, strategic business operations, patient experience, healthcare ICT and security is safeguarded.

At ConsultAssistent, we have all the necessary disciplines in house. Every day, we strive to stay ahead of the market and let our customers get the most out of ConsultAssistent. Our daily team consists of, among others: UX specialists, module developers, technical developers, data scientists and implementation specialists.

As a company, we are more than our product; we are agile and go for demonstrable results. Together with our founders, we have access to a large network with a lot of expertise and influence.

INTEREST?

If so, please contact Rountree. You can reach at or by email at .