Mission & Company Introduction:
POROUS, a pioneering healthcare technology company founded in 2021, is dedicated to the early detection and prevention of osteoporosis. Leveraging our innovative quantitative ultrasound technology and intelligent algorithms, POROUS offers a non-invasive solution for assessing cortical bone quality at a microscopic level. Our groundbreaking approach revolutionizes the diagnosis and management of osteoporosis, making a significant impact on healthcare.
About the Role:
The Quality Specialist supports the Quality Management Representative (QMR) in maintaining, monitoring, and further developing the Quality Management System (QMS) in accordance with ISO 13485 and the regulatory requirements of Regulation (EU) 2017/745 (MDR).
The company places on the market ultrasound devices for cortical bone microstructure assessment. The Quality Specialist ensures that all quality-relevant processes are documented, monitored, and continuously improved to guarantee the safety and performance of the devices.
Your Tasks:
- Support in maintaining and updating QMS documentation (processes, procedures, work instructions, forms).
- Support in planning, preparing, and conducting internal audits and management reviews.
- Support during external audits (Notified Body, authorities, customers).
- Tracking and follow-up of actions resulting from audit findings and management reviews.
- Support in qualification, evaluation, and periodic re-evaluation of suppliers and service providers (e.g. OEM manufacturers, development partners, test laboratories, logistics and service providers).
- Maintenance of supplier files and records, including performance assessments and follow-up of corrective actions.
- Collection, documentation, and initial assessment of feedback, complaints, and incidents.
- Support in the preparation of trend analyses, PMS reports, and periodic summaries as required by MDR.
- Maintenance and organization of PMS and vigilance documentation in accordance with Articles 83–86 MDR.
- Support in maintaining and updating risk management files according to EN ISO 14971.
- Assistance in compiling and updating technical documentation for the devices (e.g. risk management file, usability documentation, clinical evaluation documentation – in coordination with responsible functions).
- Provision of quality-related data and documentation for Notified Bodies and competent authorities.
- Support during certification and surveillance activities (e.g. ISO 13485 audits, MDR conformity assessments).
- Monitoring implementation deadlines and supporting effectiveness checks of CAPA measures.
Your Profile:
- Basic knowledge of ISO 13485:2021, ISO 14971:2019, and EU Regulation 2017/745 (MDR).
- Experience with quality management systems or regulatory documentation in the medical device sector is an advantage.
- Experience with QMS or DMS software (eQMS).
- Experience with Confluence and Jira.
- Good command of written and spoken English; German or other languages are an advantage depending on company context.
- Analytical, accurate, and structured way of working; high sense of responsibility and reliability.
What We Offer:
- An international high end MedTech company where your work makes the difference for osteoporosis patients.
- A key quality assurance role in a mission-driven MedTech company.
- Flat hierarchy, lots of freedom, real ownership.
- Flexible work environment with an office in Berlin and Potsdam, as well as the possibility of mobile working.
- Discounts on lunch (team lunch), compensation for transportation (Deutschlandticket) or other benefits.
- A competitive gross monthly salary depending on your experience, knowledge of the field, etc.
- An international team of experts from diverse backgrounds.
- A dynamic and collaborative work environment.
- Flexible working hours and 30 days holiday p.a.
- Frequent opportunities for further professional education.