QA Engineer

3 weken geleden

The Hague South Holland Netherlands, NL Corsano Health Voltijd

Job Title: Quality Assurance Engineer (QA)


Requirement: You must have ISO 13485 and EU Medical Device Regulation (MDR) knowledge and experience


Location: In-person at Corsano Health, Geneva or The Hague


Job Type: Full-Time


About Corsano Health: Corsano Health is at the forefront of developing, producing, and selling medically certified wearables for continuous vital sign monitoring. Our flagship product, the Corsano Solution, is a CE MDR certified and FDA Cleard system designed to monitor a.o. pulse rate, blood pressure, respiratory rate, SpO2, temperature and activity. We are committed to innovation and excellence in the medtech sector, and we are looking for a talented QARA Manager to join our dynamic team.


Job Description: Corsano Health is seeking a hands-on QA Engineer to Implement & maintain the Quality Management System (QMS) is compliant with ISO 13485 and EU Medical Device Regulation (MDR) requirements. The QA Engineer will be responsible for maintaining and improving our Quality Management System (QMS) to ensure compliance with regulatory standards. You will work closely with cross-functional teams, including software developers and product managers, to manage quality processes and documentation for medical device development. This position reports to the COO.


Key Responsibilities:


1) Quality Management System (QMS):

  • Maintain and improve the QMS in compliance with ISO 13485 standards and CE MDR requirements.
  • Ensure all QMS-related documentation is up-to-date and properly controlled.
  • Lead internal audits and support external audits.


2) Documentation Management:

  • Follow up with developers and other teams to ensure timely completion of SRS (Software Requirements Specifications), SDS (Software Design Specifications), test reports, and other technical documents.
  • Review, update, and manage technical files and design history files.
  • Follow up and ensure timely completion of the Feedback Register to comply with Post-Market Surveillance (PMS)requirements, addressing customer feedback, incidents, and field performance data.Ensure traceability and version control of all documentation.
  • Ensure traceability and version control of all documentation.


3) Process Improvement:

  • Identify and implement process improvements to enhance efficiency and compliance.
  • Provide training to the team on quality and regulatory processes.


4) Product Testing and Validation:

  • Support verification and validation activities.
  • Ensure test protocols and reports are properly documented and aligned with standards.


Qualifications:


· Bachelor’s degree in Engineering, in the field of life sciences / technical or medical devices; preferably knowledge of electronic devices (hardware, software and firmware).

· 3+ years of experience in quality assurance within the medical device industry.

· Strong knowledge of ISO 13485 and CE MDR.

· Experience with software as a medical device (IEC 62304) is a strong advantage.

· Familiarity with FDA 21 CFR Part 820 is a plus.

· Hands-on experience in a startup or scale-up environment is highly desirable.

· Proficiency with document control systems and QMS software.

· Strong attention to detail and organizational skills.

· Excellent communication and collaboration skills.

· Fluency in English (written & spoken).


Benefits:

· Competitive Compensation: Attractive salary and performance-based incentives, aligned with company growth and leadership progression.

· Professional Development: Access to leadership training, industry conferences, and a network of seasoned mentors to support your growth.

· Innovative Work Environment: Join a cutting-edge, mission-driven company that fosters collaboration, creativity, and continuous improvement.


This is an exciting opportunity to join a fast-growing HealthTech company at a pivotal moment of expansion. As QA Engineer, you will play a key role in ensuring regulatory compliance and maintaining the highest quality standards for innovative healthcare solutions. Your expertise will drive regulatory strategies, shape the Quality Management System, and help bring life-changing technologies to market. This role offers the chance to make a meaningful impact while advancing your career in a dynamic, mission-driven environment.


How to Apply: Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience and why they are a great fit for this role to info@corsano.com. Please include "QA Engineer" in the subject line.


Corsano Health is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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