(Senior) Director Quality Efficiency & Optimization
Key Responsibilities:
- Lead continuous improvement initiatives, driving cultural and operational changes to integrate quality system, product, and process improvements into everyday business.
- Identify and enhance areas within the MSCQ network to ensure compliance while maximizing flexibility and efficiency.
- Harmonize MSCQ practices across sites (e.g., Validation, Process Control, and Test Methods).
- Develop and implement robust, sustainable, and efficient processes, methods, and procedures.
- Collaborate with process owners and stakeholders to implement lasting improvements.
- Provide quality leadership and hands-on support to FMCNA sites facing acute issues (e.g., product quality problems, process capability issues, FDA inspections).
Key Deliverables:
- Implement efficiency improvements within QOEHP
- Monitor and report QOEHP progress (including Master Project List and dashboard) to senior management
- Lead the QOEHP Core Team to identify and drive efficiency opportunities, collaborating with Manufacturing Quality, Supplier Quality, and Supply Chain Quality
- Manage the overall QOEHP program
- Establish a network of Subject Matter Experts (SMEs) in technical areas (e.g., inspection and test)
Required Experience:
- At least 10 years of experience in Quality Assurance, Quality Engineering, and/or Quality Systems, preferably in the Medical/Pharma industry
- Minimum of 3 years in a senior management or leadership role
- Proven experience in implementing global processes/standards
- Advanced project management experience
- Hands-on experience in a GMP/GDP environment
- Strong collaborative skills with excellent interpersonal and communication abilities, along with political awareness
- Ability to manage complex programs involving external organizations, partnerships, and diverse stakeholder groups
- Familiarity with FDA, MDD/MDR, and key international regulations for both devices and drugs
- Experience in talent development within a global engineering/scientific organization.
- Fluency in English; additional languages are a plus
Our offer to you
There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:
- The opportunity to work on a mobile basis
- Whether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together
- A large number of committed people with a wide range of skills, talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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Our values
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.