Quality Assistant for Dot Kitchen
We are the digital health company behind Sensor Dot, a powerful wearable platform for 24/7 acquisition of physiologic and behavioral data. We have developed remote monitoring applications for COVID-19, epilepsy and cardiovascular diseases, and have a pipeline of additional clinical indications. Currently, we are looking for a software developer for our OncoCare@Home solution.
Byteflies is structured in autonomous cross-functional teams that all have skills to complete their own part of the Byteflies mission. All of these teams have great autonomy in reaching their goals. We are looking for an entrepreneurial colleague with lots of energy and passion to spread the telemonitor gospel and change the lives of patients and doctors.
QA Buzzword Bingo
Buzzwords for this role are ‘kitchen review’, ‘incoming inspection’, QMS, GMP, CAPA, ‘calibration’ & ‘continuous improvement’.
Some of them should probably ring a bell if you think this role might fit you (smiley)
- Kitchen review: the process where we check the quality of the outgoing products (patient boxes) so we can demonstrate that the batch was manufactured according to procedural and regulatory requirements
- Incoming inspection: we perform inspection of sourced components that were delivered, and incoming inspection of returned goods. After a person has used a Byteflies telemonitoring solution, the patient box is sent back to us and specific components shall be refurbished.
- GMP = Good Manufacturing Practices. Our quality ninja will be the one making sure we apply GMP practices & procedures ((GMP)procedures relating to hygiene, clothing(ESD safety), health, material flow, components and manufacturing)
- QMS: “ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.” Byteflies produce medical devices and our work needs to meet high standards and consistent quality. As quality assistant you will be a driver of continuous improvement, improving procedures & work instructions.
- Calibration: you ensure that calibration requirements for kitchen equipment is correctly set up & documented and you take care of the registration of this in our QMS
Quality is teamwork
In collaboration with your colleagues you work out solutions regarding specific quality problems that are identified during incoming inspection, refurbishment and production.
This role is NOT
…. a QA position, focussing solely on processes and procedures that improve Quality (and prevent defect) by monitoring and verification.
… a QC position; focussing solely on the product, to find defects in pre-production, during production and post-production
This role is a Quality role; focussing on continuous improvement of quality (cleanliness, working according to procedures, correct reporting) and reliability of execution (availability of equipment/tools according to QMS, minimum approved quantities, consolidation of the 'savoir faire')
We will be on the lookout for
- Experience in the quality control or quality assurance domain
- knowledge of GMP in medical technology, medical devices, pharmaceuticals or a comparable sector
- Knowledge of quality standards and manufacturing processes
- Administrative super powers: you like admin, you’re meticulous and structured
- Reactivity and sense of priorities
- someone who is excited to be part of an impactful team that wants to revolutionize wearable health
- A possibility to take part in our journey to enable out-of-hospital monitoring and the chance to have a direct impact on people’s health care
- Growing with Byteflies will unlock rapid professional growth and lots of new challenges
- A bunch of awesome colleagues who will challenge you to keep learning
- A working environment based on real autonomy & responsibility
- A competitive salary and benefits package is of course part of the deal