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)