Quality Manager

at  CompuGroup Medical

We are a leading company in the medical software industry dedicated to improving healthcare through innovative technology solutions. We are seeking a highly skilled and experienced Quality Manager to oversee our Quality Management System (QMS) for one of our products and ensure our processes comply with company standards, ISO standards, and legal requirements specific to medical software in Germany.
Job Description: As a Quality Manager, you will be the owner of the QMS and responsible for the processes within one of our key departments. You will play a critical role in supporting and guiding the team in writing and maintaining processes that align with company standards, ISO standards, and legal requirements such as GDPR and C5 (Cloud Computing Compliance Criteria Catalogue). The ideal candidate will be familiar with agile methodologies and demonstrate expertise in software capability models, software engineering excellence, and lean management.

Key Responsibilities:

• Own and manage the Quality Management System for the designated department.
• Lead the development, implementation, and continuous improvement of quality processes.
• Ensure compliance with all relevant ISO standards, company standards, and legal requirements including GDPR and C5.
• Support and guide the team in documenting and maintaining processes.
• Train and mentor team members on quality standards and best practices.
• Collaborate with cross-functional teams to integrate quality management into software development lifecycle.
• Facilitate agile practices and promote software engineering excellence and lean management within the team.
• Conduct regular audits and assessments to ensure compliance and identify areas for improvement.
• Stay updated with industry trends, standards, and regulations relevant to medical software.

Requirements:

• Bachelor’s or Master’s degree in Quality Management, Software Engineering, or related field.
• Proven experience as a Quality Manager or similar role, preferably in the medical software industry.
• Extensive knowledge of ISO standards, GDPR, and C5 as they apply to medical software in Germany.
• Strong understanding of agile methodologies and experience in implementing them.
• Experience with software capability models e.g. CMMI, SPICE … etc
• Experience with software engineering excellence and lean management is a plus
• Excellent leadership, communication, and organizational skills.
• Fluent in English; German is a plus.

• Own and manage the Quality Management System for the designated department.
• Lead the development, implementation, and continuous improvement of quality processes.
• Ensure compliance with all relevant ISO standards, company standards, and legal requirements including GDPR and C5.
• Support and guide the team in documenting and maintaining processes.
• Train and mentor team members on quality standards and best practices.
• Collaborate with cross-functional teams to integrate quality management into software development lifecycle.
• Facilitate agile practices and promote software engineering excellence and lean management within the team.
• Conduct regular audits and assessments to ensure compliance and identify areas for improvement.
• Stay updated with industry trends, standards, and regulations relevant to medical software