Quality Specialist (Laboratory Diagnostics) in Bucuresti

The Opportunity For our Core DiagnosticsDivision CDxwe are looking for a highly motivated, self-driven professional to join our regional, EEMEAP quality team as a Quality Specialist.This position will work out from our office in Bucharest, Romania.Primary objective and impact of the role:SupportsQuality System compliancein a specific region or regions.Supports a specific process or processes for the whole Europe/EEMEAP as Subject Matter Expert (SME), its backup, or part of the team.Operates under Quality and Regulatory directives and Abbottpolicies and procedures.Follows local regulations and international industry/Quality Systemstandards.What You'll do:Supports the ManagerQARegion to ensure Europe/ EEMEAP and RegionQuality Systemeffectiveness and compliance.Performs internal, storage facilities andsupplier audits.Supports / prepares/ coordinates external audits.Review & approve locally developedAdPromomaterial in local language on behalf ofRegulatory Affairs.Supports the EEMEAP commonQuality Systemand QS processes: e.g. Field communications,supplier evaluation, audits andCAPA, warehousing, AdPromo,document controlandrecord keeping.Review Abbott policies & procedures, and update Quality documentation accordingly.Manage any audit input by initiating changes to affected processes following MIMSchange controlprocedures.Required qualifications and background:University degree in life science or related scientific background (i.e. Lab Technician, Biology,Chemistry, Pharma, M.D.,Engineer) preferred.At least 3 years of experience inQA, RA roles (preferably in diagnostics,medical devicesor pharmacy), preferably in an international environment.Quality Assurance in a commercial affiliate at the diagnostic/ medical device/ pharmaceutical industry is preferred.Native or bilingual level ofRomanianlanguage is a must.Excellent command of written and spokenEnglish is amust.Strong attention to details and high working culture.Strong teamwork skills, including working with international teams.Readiness to travel (approx. 5-10% of time).Readiness to work in an office-based model.Experience to work in international environment/ projects is preferred.