The function assures that all water treatment systems (WTS) and concentrate delivery and production systems are set up to achieve the dialysis fluid quality in compliance with the corresponding FME standards as well as legal and other external requirements in the most efficient way, at regional level and collaborate with the local technical operations. This is mainly achieved by establishing and maintaining a proper operational monitoring, microbiological and chemical test system as well as supporting the required system validation, monitoring and training system.
Tasks performed regularly which form the essential characteristics of the position.
Operations according to Care Delivery International APAC Water Quality Standard
• Implementation of a monitoring, reporting and training system related to dialysis fluid quality and water treatment system parameters as input for data evaluation (e.g. quarterly reporting of relevant parameters by the clinic to country headquarter) including
• Training of qualified personnel for routine monitoring and water quality related activities
• Approval of accreditation of proper laboratory
• Supervise WTS and dialysis fluid quality monitoring process in dialysis clinics including:
• Periodic evaluation of routine monitoring results (e.g. data correctness, compliance with fluid quality requirements)
• Root-cause analysis and risk evaluation in the case of critical deviations in dialysis fluid or WTS parameters, with the assistance of regional & local Technical Operation and Nursing and Clinic Quality Management Team.
• Performance of risk assessments for e.g. concurrent validation, deviations from requirements, etc.
• Execution of immediate correction and corrective actions / risk reduction measures in case of critical deviations of dialysis fluid quality or water treatment parameters, with the assistance of regional & local Technical Operation and Clinic Quality Management Team.
• Immediate reporting to CDI management in case of critical deviations of dialysis fluid quality or WTS parameters
• Support of the responsible functions at clinic and country level in implementation of
• Work with local Technical Operations Team (TO), Project Planners (PP) and external vendor (if required) to the selection of water treatment and concentrate delivery systems, validation, routine monitoring, disinfection and sampling plans, etc. to ensure the proper operations of the WTS
• Immediate correction and corrective actions in the case of deviations of dialysis fluid quality or WTS parameters
• Gap analysis based on the retrospective annual validation and legal requirements including evaluation of resulting costs (i.e. project management for the directive implementation)
• Optimise dialysis fluids and water treatment related costs in cooperation with e.g. real estate and facility management function in compliance with FME’s eco-control targets, with the assistance of the local TO/PP
• Planning of validation and re-validation processes, with the assistance of the local TO/PP
• Training of qualified personnel in the implementation of the validation/re-validation processes
• Cooperate with interface at local and at corporate headquarters, e.g. Technical Operations, Care Operations Establishment of network and close collaboration with technical experts, e.g. clinic technicians, WT project engineers, etc. and international FQR community
• Define targets and follow up on achievement
• Document all relevant reports, e.g. re-/ validation, risk assessments, disinfection and sampling protocols etc. in an organized and well-structured way
• Support local country organisation and management during internal and external audits by providing audit relevant documents and participation during audit
• Supervise and support the APAC Country FQR.
Quality, Legal & Compliance
• Follow and comply with all relevant FME policies, guidelines, manuals and SOPs in the version as amended from time to time (“FME Policies”)
• Keep yourself updated about the current version of the FME Policies that are relevant for your role and integrate corporate values in daily business
• Legal requirements must be considered for defining the local responsibilities on authorization / release of dialysis fluids production equipment in the dialysis clinics (e.g. medical director, centre responsible, pharmacist)
Key Performance Indicators
• Provide information to respective Country Managing Director, Area Manager of business location in APAC, and participate in optimising total cost of ownership for water treatment systems.
• Reduction of WTS’ contamination incidence rate
• Meeting legal & regulatory requirements and Local & FME compliance standards
Qualifications, experience, know-how and skills critical for success*
1) Required training and education:
• Academic degree with additional specialized qualification or subject-related education, preferably in technical, engineering or healthcare services
• Project Management Experience on Water Treatment Systems
• Knowledge on international and regional regulations on Water Treatment Systems
• Preferably, Corporate FQR’s qualification training on international/local legal regulations, corporate water directives, microbial management and basic WTS engineering
2) Required professional experience (in years):
At least 2-4 years professional experience in equivalent or similar functions ideally in a technical, engineering, healthcare or healthcare-related business environment
3) Required personal competencies:
• Highly professional attitude characterized by a result, quality, patient and customer-oriented working style
• High social competence paired with persuasiveness and self-confidence, high level of energy and positivity based on a sincere personality
• Team Player with a strong drive to create positive work environment, able to motivate, empower and connect teams
• Strong structured methodical approach leading to pragmatic and effective solutions
• Strong ability to set priorities and self-manage high volume workload
• High ability to think strategically and take qualitative decisions even under changing conditions or conflicting requirements
• High analytical and problem-solving skills with proven ability to organize and analyse data
• Very structured way of working with strong focus on efficient and effective processes even under pressure
• Hight level of change, negotiation and conflict management skills
• Basic skills in presentation, facilitation and training
• High resilience and flexibility
4) Other specialized knowledge, expertise and skills:
a) Technical knowledge
• Understanding of technical aspects of the water treatment system components and other related medical devices and products
• Awareness of the potential impacts of contaminated water/dialysis fluids on dialysis patients
• Chemical and microbiological knowledge related to water and dialysis fluids
• Knowledge of the applicable legal and IMS requirements
• Ability to evaluate the economic impact of decisions
b) IT skills
• Understand and use modern communication software and systems
• Good IT user knowledge (MS Office, Intranet etc.)
• Understand basics of e-health, data security and related topics
• Basic knowledge of EuClid desirable
c) Languages
• Country language and English fluent as a must (presenting, writing, reading)
• Other languages besides country language an asset
5) Special personal requirements:
Please list requirements such as willingness to travel or work weekends or shifts etc.
• Working for an international company with international standards
• Travelling within the region and international across different time zones
