Quality Expert and CSA Expert

Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees, and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on six core values supporting our promise to improve the quality of life of every patient every day. These core values are: Patients and Partners First, Honesty and Integrity, Quality and Compliance, Collaboration, No-Limits Mindset and Results Oriented.

Your responsibilities:

• Verify compliance with CSA procedures and methodologies to uphold software quality standards and requirements.

• Oversee the execution of software quality assurance processes, including testing activities, documentation reviews, and defect management.

• Monitor software development activities to identify deviations from established procedures and address non-compliance issues.

• Coordinate with project teams to ensure alignment with CSA requirements and facilitate resolution of compliance issues.

• Conduct audits and assessments of software development projects to evaluate adherence to CSA processes and identify areas for improvement.

• Provide guidance and support to project teams on the interpretation and application of CSA procedures and standards.

• Document and communicate findings from compliance assessments and audits to stakeholders, including recommendations for corrective actions and process enhancements.

• Collaborate with stakeholders to implement process improvements and best practices to enhance software quality and efficiency.

• Assist in the development and refinement of CSA processes and procedures based on industry best practices and organizational requirements.

• Support the integration of CSA practices into software development methodologies and project management frameworks.

• Stay updated on industry trends, regulatory requirements, and emerging technologies related to software quality assurance and compliance.

• Provide training and awareness sessions on CSA processes and standards to project teams and stakeholders as needed.

Our requirements:

• Bachelor's degree in Computer Science, Software Engineering, a Science or a related field or successfully completed a technical apprenticeship supplemented with appropriate professional experience in a comparable role

• 2-5 years of experience in software quality assurance or compliance roles.

• EN ISO 13485:2016 knowledge

• 21CFR Part 11 e-signature knowledge

• IT service provider/department process awareness

• GAMP 5 software validation knowledge

• Knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements

• Relevant experience with Quality system IT Platforms – e.g. Trackwise, Windchill, Agile, IQVIA etc

• Knowledge of software quality assurance standards and frameworks, such as IEEE 829 and ISO/IEC 25010.

• Strong understanding of software development lifecycle (SDLC) methodologies and quality assurance principles.

• Experience with software testing, documentation, and defect management processes.

• Good general Project & Program Management skills

• An enterprise wide mind-set – building productive working relationships

• Fluency in the English language in the business environment (at least B2)

• German language knowledge will be an asset

• Willingness to travel within Europe and in the US as needed to support projects.

Our offer:

• Private medical care in LuxMed,

• PZU life Insurance,

• Unlimited international travel Insurance,

• Benefits System platform (multisport card, cinema tickets, online shopping etc.)

• Language courses reimbursement,

• Work abroad possibility (up to 30 days / year)

• Recommendation programme

• Life milestone bonus

• Holiday allowance

• Childcare refund

• Occasional gifts