Bad Homburg, DEUPermanent positionFull time
Senior Quality Expert (QMS)
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Goal of Function:
- The Senior Quality Specialist plays a pivotal role in maintaining and enhancing the quality management system (QMS) within the IT department. This position is responsible for ensuring compliance with established processes, documentation, and controls to drive efficiency and quality in IT operations.
Tasks & Responsibilities:
- Responsible for documentation management and archiving within the QMS framework.
- Conduct QMS administrative work, including maintaining records, tracking metrics, and facilitating audits.
- Design and implement DTI (Department of Information Technology) IT processes and controls, including IT Standard Operating Procedures (SOPs), Work Instructions (WIs), and systems.
- Identify training needs for DTI IT personnel to execute assigned QMS functions effectively.
- Develop training matrices and packages to support the qualification of IT personnel in implementing QMS processes.
- Develop change management strategies, including PowerPoint decks, and communication plans to facilitate smooth transitions within the IT department.
- Collaborate with cross-functional teams to ensure alignment of QMS processes with departmental goals.
- Support continuous improvement initiatives by analyzing data and identifying areas for enhancement within the QMS.
- Participate in QMS audits and inspections, addressing findings and implementing corrective actions as necessary.
- Stay updated on industry standards and regulatory requirements related to quality management systems in IT.
- Gained knowledge in GxP compliant documentation and quality management systems (ISO 9001, GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21 Part 11, GAMP)
- Understanding the method for the management of IT departments providing GxP system support/management
- Responsible for compliance in alignment with the defined QMS processes
- Responsible for the continuous improvement of the QMS framework
Education & Qualifications:
- 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
- Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements
- 2+ years of professional experience working with or owning computer software validation/system coordination
- Additionally, minimum of 5 years of professional experience working in a medical device or pharmaceutical industry as well as an international environment would be preferred
- Experience of working in a company manufacturing under GxP environment
- Your work ethic is characterized by a strong self-motivated, systematic and analytical approach
- Pay close attention to details
- Strong communication and project management skills as well as a strong service and result oriented working style
- Good general Project & Program Management skills
- Must be a self-starter with strong creation to execution skills.
- The ability to troubleshoot and resolve system-related issues effectively.
- An enterprise wide mind-set – building productive working relationships
- Cultural sensitivity and understanding. Able to effectively deal with international/cultural differences.
- Excellent oral and written communication
- Ability to adapt to business strategy or changes in priorities
- Strong EN ISO 13485:2016 knowledge
- 21CFR Part 11 e-signature knowledge
- IT service provider/department process awareness
- GAMP 5 software validation knowledge
- Relevant experience with Quality system IT Platforms – e.g. Trackwise, Windchill, Agile, IQVIA etc
- Knowledge of computer software validation and computer software assurance principals
- Knowledge and understanding of business systems, Windows Office, Teams, Projectplace, Visio etc
- Basic familiarity with the production of medical devices or pharma products
- high language proficiency in English
- German a benefit
- Willingness to be on site as needed
- Willingness to travel within Europe and in the US as needed to support projects.
Career with a purpose
We offer an opportunity to create and deliver treatments that save and change lives for the better. We’ll support your ongoing development. And you’ll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day.
Inclusion and diversity
Joining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued.
Stability
Developing innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients.
Learning and development
We offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7.
Local benefits
Our employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere.
Work-life balance
We want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.
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At a glance
Earliest possible start:
As from now
Contract type:
Permanent position
Company:
Fresenius Medical Care
Region / Business Unit:
Global Departments
Location:
Bad Homburg (DEU)
Working condition:
Full time
Job Function:
Cyber Security
Reference number:
R0166307
Publishing date:
08/02/2024
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Collaborative
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.
Proactive
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.
Reliable
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.
Excellent
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.