You are here: Jobs / Q&R OFFICER (FULL-TIME) @ Plasmacure
Plasmacure is a fast-growing MedTech start-up focused on the treatment of chronic wounds. Our vision is: “A world where people no longer suffer from their chronic wounds.” We focus on the treatment of complex wounds, such as diabetic foot ulcers and venous leg ulcers, which not only have a huge impact on patients and their surroundings but also place significant pressure on the healthcare system. Our patented technology, PLASOMA, uses ‘cold plasma’ to accelerate the wound healing process. This technology has been fully tested and is approved for commercial use. Plasmacure has been granted the status of “Promising Healthcare” and is ready to further roll out PLASOMA both in the Netherlands and internationally, through partnerships with healthcare institutions and insurers.
About the job
As our Q&R Officer, you are responsible for the day-to-day quality and regulatory affairs activities. All aspects of quality and regulatory affairs are involved, and you report to the QA & RA Manager. This role offers a unique opportunity to be part of our journey and provides a pathway to grow towards a QA RA Manager role. Location: Eindhoven.
Key responsibilities related to quality management:
· Maintenance of the quality management system in compliance with ISO 13485. Implement QMS changes, provide QMS training, organize and lead internal audits.
· Managing the CAPA process.
· Managing the complaint process including customer communication.
· Performing component and product quality checks including incoming inspection.
· Monitor supplier quality.
· Communicate with regulators
Key responsibilities related to regulatory affairs
· Prepare and maintain technical documentation for product submissions to regulators, including EU MDR and FDA.
· Support product registrations and listings in global markets.
· Review of labelling and promotional materials
Requirements
· Education at bachelor’s or master’s level (HBO/WO) in a relevant field (e.g. Life Sciences, Engineering or Quality Management)
· Some years of work experience in medical device quality and or regulatory affairs (2–5 years)
· Knowledge of ISO 13485
· Experience with EU MDR and standards such as ISO14971 and IEC62366-1 is a plus
· Broad interests, eager to learn, flexible, and creative.
· Detail-oriented, organized, and capable of working independently in a small team.
· Proactive and flexible attitude with a hands-on mentality
· Excellent verbal and written communication skills in both Dutch and English; open and clear communicator
Our values
· Personal impact: Takes initiative and owns his/her responsibilities. Can be relied upon to deliver conform to high quality standards towards internal and external stakeholders. Develops his/her capabilities to achieve stretched targets and to positively impact the team.
· Courage: Frank, direct, structured, bold communication. Energy to stretch himself/herself and the team to new standards and opportunities.
· Teamwork: Takes initiative towards productive partnerships with internal and external stakeholders. Positively contributes to the overall team engagement and productivity.
· Empathy: Gives others the feeling that they matter. Listens well and with an intent to understand others. Communicates and supports others effectively and with an intent to achieve shared objectives.
What We Offer
· An opportunity to be part of an innovative start-up in the MedTech sector
· A dynamic and impactful work environment where you contribute to the future of wound care
· Plenty of room for personal and professional growth
· Attractive employment conditions and a positive, collaborative atmosphere within a passionate team
Are you interested in joining the Plasmacure team and do you recognize yourself in this role and our values? For questions related to this opportunity and to send your CV application please email to jobs@plasmacure.nl
“Shape your career at Plasmacure”. See you soon!
