About Pacmed

At Pacmed we develop world leading AI-based decision-support software for intensive care doctors. It’s a hugely exciting area where we’re breaking boundaries every day. We have currently implemented our software in our first ICUs, and we are currently developing new exciting features and prototypes, with the ambition to scale across the Netherlands and beyond. We’re looking for a Quality Assurance (QA) Manager who’s excited to further develop our products into impactful tools to help improve the level of medical care for as many patients as possible.

What this role is all about

As QA Manager, you are responsible for the maintenance and improvement of Pacmed’s Quality Management System. You are part of the Quality and Regulatory team and will participate in auditing- and training activities with the aim to further professionalize the organisation.

We are looking for someone who understands our business objectives and is able to ensure our quality control processes are in line with our needs and requirements. In this role you will work with people from across the organization, which makes effective project- and stakeholder management a critical part of the role. As you will directly report to our COO, you are expected to take ownership and work independently under a minimum level of supervision.

One thing you can be sure of, every day you’ll be working with an enthusiastic and mission-driven team who are passionate about using technology to revolutionize healthcare.

What would be expected of you

• Further optimize the Quality Management System in terms of efficiency and fit with the organization (we use MatrixRequirements);

• Coordinate and lead internal and external audits including positively managing the communication with the notified body;

• Responsible for root cause analysis, issue and follow-up on NCs and CAPAs including closure within the set timeline;

• Responsible for gap analysis with regards to newly published ISO standards;

• Responsible for external supplier evaluation and monitoring;

• Collect and analyze quality data and further communicate any reported trends to the management team;

• Maintain high quality standard documentation (SOP, WI);

• Foster company awareness of the Quality Management System by means of internal training, workshops and auditing activities;

• Bonus: Implement an information security system according to ISO 27001 and NEN 7510.

The perks of working at Pacmed

Why Pacmed is a great place to work

• We're a dynamic startup committed to improving healthcare globally.

• We’re committed to creating an inclusive environment for our team.

• We’re a talented bunch of people dedicated to helping each other grow.

• We foster a culture of kindness and respect.

• We're a team of ambitious and fun-loving people, with regular team events!

Requirements

Must-haves

There is no need to apply if you don’t meet these requirements, sorry!

• Master degree in Pharmacy, Medicine, (Cosmetic) Chemistry, or equivalent and five years of working experience in the medical device field;

• Managing and maintaining the Quality Management System (QMS) and continuous improvement of quality standards (ISO 13485);

• Good knowledge of MDR (Regulation (EU) 2017/745 on Medical Devices), MDSAP, HIIPA, software development life cycle (ISO 62304, ISO 82304) and any other ISO standards which are applicable to Software as a Medical Device (SaMD);

• Experience in leading internal and external audits (ISO 13485, ISO 27001).

Should-haves

We hope you bring these things as well, but don’t worry if you don’t tick all the boxes.

• Understanding of the role QA has within the overall business objectives;

• The ability to manage projects and communicate with stakeholders effectively;

• A natural drive for lean quality management and focus on operations;

• The ability to conduct root cause analysis and problem-solve effectively;

• Excellent communication skills and way of collaborating.

Nice-to-haves

These are things that would make your profile jump out!

• Willingness and ability to manage our Information Security Management System (ISMS);

• Previous experience in a (software) startup and/or scaleup environment.

At Pacmed, we think there is strength in diversity. Studies show that women and members of underrepresented communities apply for jobs only if they meet 100% of the qualifications. Does this sound like you? If so, Pacmed encourages you to reconsider and apply! Building responsible AI requires diverse perspectives, equitable practices, and integrity every step of the way. This is our commitment.

We’re looking forward to meeting you!