Quality Manager (40-60%)

As a Quality Manager at Exploris Health you are responsible for ensuring compliance with ISO 13485, IVDR (In Vitro Diagnostic Device Regulation), MDR (Medical Device Regulation), regulations governing Software as a Medical Device (SaMD). In this role, you will directly contribute to the advancement of healthcare through our AI-driven medical software, placing you at the forefront of medical technology innovation. You will play a pivotal part in maintaining and improving our quality management systems to uphold the highest standards of product quality and regulatory compliance and you will be responsible for the generation and maintenance of the technical documentation for the company’s products. 

Ideal Candidate 

We are seeking a dynamic individual, who thrives in a startup environment, is well-versed in the software development lifecycle, and possesses a strong capability for automating processes to enhance efficiency and effectiveness in upholding product quality and regulatory compliance. 

 

Maintain and develop/continuously improve the Quality Management System (QMS): 

Develop, implement, and maintain quality policies, procedures, and processes that align with regulatory requirements.
Act as Quality representative for affected processes and tasks.
Stay informed about regulatory changes and ensure that the company complies with all applicable requirements.
Own and drive (re)certification processes as required (incl. internal/external audits)
Ensure that all processes and procedures are documented, implemented, and continually improved to guarantee product quality and regulatory compliance.
Collaborate with the software development team to automate regulatory processes, enhancing efficiency and accuracy in documentation creation.

Being familiar with applicable standards and processes such as e.g. ISO 13485, ISO 14971, ISO 27001, IEC 62304 etc.
Ensure continuous compliance of the company, products, and services.
Monitor regulatory landscape for emerging requirements and ensure timely implementation, if applicable
Interpret regulatory requirements and provide guidance to cross-functional teams to ensure compliance throughout the product lifecycle.

Risk Management: 

Oversee the risk management process, including risk assessment, mitigation strategies, and risk analysis in alignment with ISO 14971 requirements. Work closely with product development teams to identify and address potential risks associated with SaMD products.

Document Control: 

Ensure that all relevant documents (e.g., procedures, work instructions, protocols) and records are correctly created, approved, distributed.
Ensure all the documents are up to date.

Training and Training Programs:

Make sure, that employees have the necessary skills and knowledge to perform their tasks in line with quality standards. 
Updating Training programs regularly.

Validation and Verification: 

Ensure that the medical software is validated and verified to ensure its functionality, safety, and performance.

Support with establishing and maintaining the technical documentation for the devices 
Ensure a high-level overview of the development process and its proper documentation. 

 

Plan and if needed conduct internal audits to assess the effectiveness of the Quality Management System and ensure compliance with ISO 13485, IVDR, and other relevant standards. Coordinate external audits by regulatory authorities and certification bodies.

 

Proficiency in EU regulations, notably the General Data Protection Regulation (GDPR), as well as familiarity with other relevant local data protection laws.
Ability to assess and mitigate data protection risks in the context of the processing activities of the organization.
Understanding of IT infrastructure, cybersecurity measures, and data management practices to ensure that data privacy principles are adhered to technically and organizationally.

 

Communication and Collaboration: 

Work closely with other departments such as development, product management, marketing & sales, customer service to optimize the quality of the medical software.
Act as key contact to notified bodies, EU representatives, and other external stakeholders.

- Bachelor’s or master’s degree in a relevant field such as IT, Science, Engineering or equivalent
- Deep knowledge of medical device regulations and standards, such as ISO 13485, ISO 14971, IEC 62304, IVDR or MDR
- Previous experience as a Quality Manager in the Software as a Medical Device industry.
- Familiarity with the software development process and experience in interacting with software development teams.
- Proven experience in leading regulatory audits and interacting with regulatory authorities.
- Excellent communication and interpersonal skills.
- Strong analytical and hands-on problem-solving abilities.
- Ability to collaborate effectively with cross-functional teams.
- A mindset focused on continuous improvement and growth, with a willingness to embrace new roles and responsibilities as the company grows.
- of scripting languages (such as Python, PowerShell, or Bash) to streamline workflows and increase efficiency in quality management processes is a plus. 
- Keen attention to detail.
- A sharp analytical mind to identify and address quality issues.
- Knowledge of healthcare systems and clinical workflows is a plus.
- Fluent and professional in English

 

Send your CV with your annual salary expectations (calculated at 100%) and availability to wendy.lang@explorishealth.com

Please also mention if you have experience in Software (SaMD), IVDR/MDR, Quality Management & IEC 62304/ISO13485 (must criteria!)