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
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.