Missions

As a Quality Engineer for Gleamer, you will be responsible for ensuring that our company’s SAMD (Software as a Medical Device) products meet regulatory and quality standards. You will work closely with the regulatory and quality team to ensure that our products comply with relevant regulations and guidelines, and that they are safe and effective for use by clinicians in radiology. You will play a critical role in the development and release of our SAMD products, and you will have the opportunity to make a significant impact on the healthcare industry.

Responsibilities

• Participate in the development and implementation of quality management systems for our SAMD products

• Ensure that our products comply with relevant quality requirements and guidelines (e.g. 21 CFR part 820, ISO 13485, etc.)

• Manage Post-Market Surveillance activities: handle the management of complaints, follow-up on the deployment of customers, management of PMS report and PSUR;

• Follow-up on the relationship with authorized representatives for the management of registrations outside of Europe and the US;

• Collaborate with cross-functional teams to identify and address quality issues, and to improve processes

• Participate in audits and inspections, both internal and external

• Train development, sales, and operations teams to quality expectations

• Stay up-to-date with quality developments in the healthcare industry, and proactively identify opportunities for improvement

Hard skills

• Knowledge of relevant regulations and guidelines, such as FDA regulations, ISO standards, and EU Medical Device Regulations

• Experience working with Software as a medical device

• Strong analytical skills and attention to detail

• Excellent written and verbal communication skills

• Fluent in English

Soft skills

• Strong problem-solving skills and ability to think critically

• Ability to work independently and as part of a team

• Strong interpersonal skills and ability to communicate effectively with cross-functional teams

• Ability to prioritize and manage multiple tasks and projects

• Willingness to learn and adapt in a fast-paced startup environment

All our job offers are open to people with disabilities.

Master’s degree in engineering, biomedical engineering, or a related field First experience in quality engineering or related roles in the medical device industry

Meeting 1: Quick introductory call (30 min) with Head of QARA

Meeting 2: Technical assessment call (1h) with Head of QARA

Meeting 3: Meeting with the team