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Role Description

This is a full-time role (located in Erpe-Mere with the flexibility for some remote work) for a Junior Electronics Engineer (EMC/Safety). The Junior Electronics Engineer will be responsible for ensuring safe electrical and mechanical operation of medical devices in compliance with international medical regulations, analyzing and mitigating any electromagnetic interferences, and supporting product design teams in identifying and resolving potential design issues. The Junior Medical Engineer will collaborate with cross-functional teams, including R&D, Quality, and Regulatory Affairs, to ensure delivery of high quality, innovative, and regulatory compliant medical products.

Responsibilities

• Support the design and testing of electronic circuits and systems for medical devices, ensuring compliance with EMC and safety regulations.
• Collaborate with cross-functional teams to understand product requirements and integrate EMC/safety considerations into the design process from the outset.
• Assist in conducting EMC tests and safety evaluations, documenting results, and recommending improvements to meet international standards (e.g., IEC 60601-1, IEC 61000).
• Participate in risk assessments and FMEA sessions to identify potential EMC and safety issues, contributing to the development of mitigation strategies.
• Keep abreast of the latest developments in EMC standards, safety regulations, and best practices within the medical device industry.
• Work with senior engineers to develop and implement design changes that improve the EMC performance and safety of medical devices.

Qualifications

• Bachelor’s degree in Electrical Engineering, Electronics Engineering, or a related field, with a strong foundational knowledge in EMC and electronic safety principles.
• Familiarity with electronic design software (e.g., Altium Designer, Eagle) and EMC testing equipment.
• A basic understanding of the regulatory landscape, particularly concerning electromagnetic compatibility and safety (knowledge of standards like IEC 60601-1 and IEC 61000 is a plus).
• Excellent problem-solving skills, with a meticulous approach to design and testing.
• Ability to work effectively in a team, contributing to collaborative problem-solving and project development.
• Eagerness to learn and adapt in a rapidly evolving field, with a commitment to professional growth and development in medical device engineering.
• Strong communication skills, capable of documenting and presenting findings and recommendations clearly and concisely.

At Qity, we are committed to the professional development of our team. The successful candidate will receive comprehensive training and support, gaining valuable skills and experience in various areas of medical device development and regulatory compliance.

If you have a passion for developing medical devices, an eagerness to learn, and a desire to work in a fast growing MedTech start-up, we encourage you to apply for this opportunity.

Role Description

Qity is seeking a motivated Software Test Engineer to join our dynamic team. This full-time, hybrid position involves working remotely and from our offices in Erpe-Mere. In this role, you will ensure the highest quality of Qity's and Qity's customer's software products through rigorous testing, validation, and documentation processes. You will collaborate with cross-functional teams to design, implement, and execute test plans, contributing to the continuous improvement of software solutions designed and developed for the medical industry.

Responsibilities

• Develop and execute detailed test plans, test cases, and test scripts.
• Perform various types of testing (functional, regression, integration, system, and user acceptance testing).
• Integrate service management as part of defect investigations and problem management.
• Identify, document, and track software defects.
• Collaborate with developers to reproduce, analyse, and resolve software defects.
• Ensure that software meets specified requirements and adheres to quality standards.
• Participate in code reviews and actively provide feedback.
• Maintain and improve automated test scripts and frameworks.

Qualifications

• Bachelor’s degree in Computer Science, Information Technology, or a related field.
• Basic understanding of software development and testing methodologies.
• Familiarity with testing methodologies
• Comfortable with data manipulation techniques
• Knowledge of programming languages such as Python and Javascript
• Ability to write and maintain scripts for test automation
• Strong analytical and problem-solving skills with attention to detail.
• Good communication skills in English; proficiency in Dutch is a plus.
• Ability to work both independently and as part of a team.
• Eagerness to learn and adapt in a fast-paced environment.

At Qity, we are committed to the professional development of our team. The successful candidate will receive comprehensive training and support, gaining valuable skills and experience in various areas of software testing and quality assurance.

If you are passionate about developing high-quality software, eager to learn, and wish to work in a growing MedTech start-up, we encourage you to apply for this opportunity.

Role Description

Qity Clinical, a specialized service provider offering expert Clinical Affairs consulting to life science companies, is seeking a motivated and detail-oriented Clinical Research Associate (CRA) to join our team. This role goes beyond a standard monitoring role, offering a wide variety of tasks and involvement in project management, making it an excellent opportunity for professional growth. As a CRA at Qity Clinical, you will play a key role in supporting our clients' clinical development strategies. The candidate will work primarily from the Qity Clinical office, but may also be allocated to client sites and travel to study sites as needed.

Responsibilities

• Conduct on-site and remote monitoring visits to ensure compliance with study protocols, GCP/ICH guidelines, and relevant regulations.
• Verify the accuracy and completeness of source documents and case report forms (CRFs).
• Monitor patient safety and report any adverse events or protocol deviations.
• Ensure proper handling and storage of investigational products.
• Train and support study site staff on protocol requirements and data collection procedures.
• Prepare and submit monitoring visit reports and follow-up letters.
• Assist in the resolution of data queries and discrepancies.
• Maintain accurate and up-to-date study documentation.
• Collaborate with study site personnel, project managers, and other team members.
• Contribute to the preparation of study-related documents and reports.
• Assist in the preparation and conduct of investigator meetings.
• Support the Trial Master File (TMF) maintenance and audit readiness.
• Participate in varied clinical project management activities.
• Assist in the building and maintenance of electronic clinical trial management systems.
• Contribute to the development and writing of standard operating procedures (SOPs).

Qualifications

• Master’s degree in a scientific field is preferred.
• Experience in clinical research, either through employment or education.
• Familiarity with good clinical practice guidelines (ISO 14155 or ICH-GCP) or a strong willingness to learn.
• Understanding of clinical trial procedures and regulations.
• Strong computer skills (including proficiency in Microsoft Office Suite).
• Strong organizational and time management skills.
• Attention to detail and accuracy.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Willingness to travel to study sites as required.
• Quick learner with a proactive attitude.

Why join Qity Clinical?

Qity Clinical offers a unique opportunity to contribute to impactful clinical affairs consulting. As a starting company, we provide a dynamic and collaborative work environment where you can:

• Play a key role in the development of our clinical affairs services.
• Gain experience with a variety of clinical studies and therapeutic areas.
• Learn and apply best practices in clinical trial monitoring.
• Benefit from significant career growth opportunities due to the varied nature of the role.
• Contribute to the success of important clinical research.
• Work in a supportive team environment.
• Gain broad experience in clinical affairs, including project management, systems building, and SOP development.
• We offer a flexible Work From Home (WFH) policy.
• We prioritize creating an environment that fosters flexibility, growth, and personal development.

Role Description

Qity Clinical, a specialized service provider offering expert Clinical Affairs consulting to life science companies, is looking for a highly skilled and scientifically driven Clinical Affairs and Clinical Program Manager to lead and manage clinical programs for our life sciences clients. This role requires a strategic leader with a strong scientific background, capable of overseeing all aspects of clinical affairs and program management, from planning and execution to managing vendor selection, regulatory submissions, and key opinion leaders (KOLs). As a Clinical Affairs Manager at Qity Clinical, you will play a crucial role in shaping our clients' clinical development strategies, ensuring scientific rigor and regulatory compliance.

Responsibilities

• Lead and manage clinical programs, from strategic planning and protocol development through to clinical study reports and regulatory submissions.
• Provide scientific and clinical expertise to support the design and execution of clinical trials, ensuring alignment with regulatory requirements and scientific objectives.
• Develop and manage clinical trial budgets
• Lead clinical vendor bidding, contract negotiation, and oversight of vendor performance.
• Identify, engage, and manage relationships with key opinion leaders (KOLs) to support clinical development activities and scientific initiatives.
• Oversee vendor selection and management, ensuring quality and adherence to project timelines and budgets.
• Develop and maintain essential study documents, including protocols, investigator brochures, clinical evaluation reports, and regulatory submissions.
• Oversee monitoring and analysis of clinical data, ensuring data integrity and adherence to GCP/ICH guidelines.
• Provide scientific input and support for regulatory interactions and submissions.
• Manage and coordinate activities of cross-functional teams, including clinical operations, data management, biostatistics, and regulatory affairs.
• Proactively identify and address potential risks to clinical programs.
• Support the preparation of scientific publications and presentations.
• Contribute to Qity Clinical's business development and expansion.

Qualifications

• Permission to work in Belgium, Europe.
• Bachelor’s or Master’s degree in a life sciences field.
• Extensive experience in clinical affairs and program management, with a strong scientific background and understanding of clinical development processes.
• Proven experience in managing clinical trial budgets, vendor bidding, and vendor oversight.
• Demonstrated ability to identify, engage, and manage relationships with key opinion leaders (KOLs).
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Strong analytical and problem-solving skills, with the ability to interpret and analyze complex scientific data.
• Experience with regulatory submissions and interactions with regulatory authorities.
• Strong leadership and team management skills, with the ability to motivate and inspire cross-functional teams.
• Excellent communication, interpersonal, and presentation skills.
• Strong problem-solving and decision-making abilities.
• Proficiency in clinical trial management systems such (CTMS), Trial Master File (TMF) and electronic data capture (EDC) systems.
• Strong computer skills.
• Ability to travel as required.
• The candidate will work primarily from the Qity Clinical office, but may also be allocated to client sites as needed.

Why join Qity Clinical?

Qity Clinical offers a unique opportunity to contribute to impactful clinical affairs consulting. As a starting company, we provide a dynamic and collaborative work environment where you can:

• Play a key role in the development of our clinical affairs services.
• Gain experience with a variety of clinical studies and therapeutic areas.
• Learn and apply best practices in clinical trial monitoring.
• Benefit from significant career growth opportunities due to the varied nature of the role.
• Contribute to the success of important clinical research.
• Work in a supportive team environment.
• Gain broad experience in clinical affairs, including project management, systems building, and SOP development.
• We offer a flexible Work From Home (WFH) policy.
• We prioritize creating an environment that fosters flexibility, growth, and personal development.