Product Quality and Risk Management Support (m/f/d)

Your assignments in the Product group Concentrates and Disinfectants :

Product Quality expertise

• Coordination of major quality issue management including root cause analysis, CAPA and follow up analysis
• Monitoring and reporting of quality KPIs analyzing trends and failure trend analysis
• Preparation and periodically update of management review presentation and leading quality review meeting within the Product Group network
• Preparation of post market surveillance data per product groups (PMS, PSUR input, IMDRF analysis)
• Link to central complaints and vigilance organization for data exchange and data analysis

Responsible for Risk Management activities

• Periodically or specific events (e.g. : development projects upon request, customer complaints, design changes, market surveys, post market surveillance, ad hoc request by CSO, etc.)
• Product Risk classification / Completion and Maintenance of Risk file and preparation and approval of Overall risk Evaluation sheet.
• Assemble expert opinions to a risk evaluation in case of requested FSCA
• Coordination of Team in charge of root cause analysis or investigation for major quality issues (eg. set up of adhoc Task Force)
• Driver for improvements potential for quality related processes by using specific methodology and tooling (e.g. pFMEA)
• Team member for performing Risk analysis for products, components, process in case of a design change
• Supporting function in case of Notified Bodies / Authorities audits for Risk Analysis documentation review

Your profile :

• Bachelors Degree with a Technical / Engineering / Scientific background
• Experience of minimum 5 years in Quality or regulatory affairs in pharmaceutical / medical device field
• Advanced knowledge of medical device risk management and related regulations
• Advanced knowledge of Risk Management and medical device regulations (ISO14971, NMPA regulation, MDD 93 / 42 / EEC, MDR 2017 / 745, MDSAP etc.)
• Advanced knowledge of applicable standards (e. g. ISO13485, ICH Q10, EU GMP, FDA 21 CDR 820.250, etc.)
• Knowledge of internal and external processes and structures and of the corporate Quality Management requirements
• Knowledge of CAPA methodology and Complaint Handling
• Knowledge in statistical methods
• Experience with QTRAK and PDM systems as PTC Windchill are an advantage
• Fluent in English (written and spoken)

Career with a purposeWe 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 diversityJoining 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.

StabilityDeveloping 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 developmentWe 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 benefitsOur 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 balanceWe 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.