Development QA Engineer

An International Medical Device company that develops and manufactures innovative medical equipment. Specifically, we develop infusion pumps and their related accessory products. We are looking for a talented and motivated engineer for the Quality Assurance Department.
 
Job Description:
The development QA Engineer will be a part of the product QA team;
He/she will be a QA focal point for the R&D projects for new and commercial products.  
Attend R&D project routine meetings as the product QA team representative.  
Review and approve deliverables and additional documents which are required for the R&D projects according to internal SOPs and regulatory requirements.  
Participate in risk-evaluation processes related to R&D projects as the product QA representative.  
Act as a QA leader of change controls initiated throughout the R&D products and for commercial products.  Conduct QA activities relating to data analysis and statistics, calibrations, SOP reviews and approvals, audit tasks and support of non-conformity investigations.   
Direct manager: QA Product Team Leader
 
Job Requirements:
Education: B.Sc. in BiomedicalBiotechnologyChemical Engineering   
Job Skills: At least 2 years experience in QA or RA, preferably with R&D  projects, in a medical device or pharma manufacturing company according to GMP and regulatory requirements (FDA QSR 820, ISO 13485)              Auditor qualification – an advantage     
Experience in supporting sterile production – an advantage           
Computer Skills: Full proficiency of all MS-Office applications  
Language skills: English – fluent (reading, writing and speaking)   
Personality: Motivated, committed, creative, team player and proactive.