Fresenius Medical Care is the world’s leading provider of products and services by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day. Our plant in Vrsac (VRC) manufactures hemodialysis bloodlines. Apart that, in our plant we produce PD sets and perform injection molding, as part of manufacturing bloodlines systems. In this role, you will oversee ensuring quality analysis results, implementation of analytical methods in routine work, implementation of corrective and preventive measures (CAPA) related to the quality management system. You are supervising in-process and final control of production of medical devices in our VRC plant in Serbia, which operates with a team of 1300 employees across eight production lines. The plant runs on a 7-day schedule, with four shifts daily. In this position you will report to the Head of the Quality control Department. 

Tasks

•    Implements the developed analytical methods in routine work
•    Conducts routine tests and monitors the implementation of the implemented Work Instructions and Analytical Methods
•    Checks and certifies test reports and other documents created as a record of test activities
•    Performs the release of semi-finished products
•    Collects data on product quality (set KPIs for product quality)
•    Documents, investigates, analyzes, plans and implements corrective and preventive measures (CAPA) related to the quality management system
•    Performs validation of analytical methods, processes data and writes validation reports.
•    Performs preventive maintenance of laboratory equipment, ensures its correctness
•    Conducts validation of production processes
•    Documents claims for suppliers of raw materials
•    Investigates customer complaints

Profile

Your personality is characterized by a high level of ability to organize processes and perceive changes accurately and quickly. The quality control associate is responsible for inspecting the product for quality assurance purposes. This position involves supervision of analyzing samples, measuring product characteristics, identifying defects, and implementing corrective measures. You are pragmatic, process oriented and open for new ways of working.

•    Bachelor’s degree (natural sciences, technology or pharmacy) 
•    Without work experience or with work experience in the same or similar jobs
•    Preferred knowledge of laws and regulations that regulate the field of releasing a series of medical devices into market, in order to ensure the quality and safety of each series of medical devices
•    Preferred knowledge of regulations governing the field of quality control of medical devices, in order to ensure the quality and safety of each batch of medical device and the quality of the medical device during the manufacturing process
•    Preferred knowledge of the validation process
•    English language (high or advanced level mandatory)
•    Advanced IT skills (MS Office - mandatory, SAP system knowledge is preferred)