Quality and Regulatory Manager - Granarolo dell'Emilia
1 mese fa
Job summary
The Quality and Regulatory Manager must possess experience in a manufacturing industry with increasing responsibilities in Quality Engineering and Regulatory Affairs Strong focus on quality systems e.g ISO 13485 21CFR 820 and on main Regulatory framework to obtain product approvals from foreign competent authorities FDA MDR MDD etc Plans and oversees activities for product assurance program to prevent or eliminate defects in new or existing products by performing the following duties personally or with collaboration with other employees Ensures the promotion of awareness of regulatory customer requirements throughout organization Develop six sigma lean thinking throughout organization Nonconformance suppliers management continuous improvement He/she will bring new product processes market time budget Apply techniques processes teach mentor best practices Lean Six Sigma Management System deployment DFM DFA DOE FMEA VA VE etc Must possess strong experience regulatory activities post marketing surveillance clinical activities CE marking activities He/she will responsible bringing new product processes market time budget Analyzes evaluates presents information concerning factors business situations production capabilities manufacturing problems economic trends design development existing products Develops document control Suggests alternative methods procedures solving problems meeting changing market opportunities Establishes QA processes responsible inspection manufactured parts Devises sampling procedures controls continuous improvement business processes Evaluates contents product assurance programs confers personnel formulating product assurance program Visits confers representatives material component vendors customers obtaining information related supply quality capacity vendor meet orders vendor quality standards Confers engineers about assurance new products designed manufactured products market rectify problems Compiles writes training material conducts training sessions control activites Develops implements methods procedures disposition discrepant material devises assess cost responsibility Manage Post Marketing surveillance activites periodic update PMS plan report PMF data elaboration FSN/FSA management Vigilance activites Prepare review maintain technical documentation support MDR transition Manage extra EU registration Interface areas company technical documentation preparation CE marking process Adhere Company s Quality Safety Management System accordance procedures requirements Perform duties assigned Supervisory Responsibility Manage QA RA team employees Requisiti EDUCATION EXPERIENCE Bachelor Degree field Prefer Master degree equivalent more than three years related experience combination education experience Working Knowledge Quality System appropriate regulations standard Knowledge Regulation MDR MEDDEV NBOG guidances FDA guidances submission process SKILLS Proven experience Quality Engineering minimum three years biomedical companies Must have written verbal communication skills read write English fluently ability interact levels customers supplier competent authorities Experience literature research database PubMed Cochrane Embase Scopus Ability read interpret write technical documents Experience ERP systems including Module bill materials workflow routing preferred Position requires initiative ability work independently produce highest level of quality productivity established standards Self-motivated multi-task oriented Strong knowledge Microsoft Office Project SAP Preferred Attention detail recognize discrepancies Altre informazioni WORK ENVIRONMENT This job operates office environment manufacturing environment Role routinely uses standard office equipment Individual required adhere safety policies procedures manufacturing floor PHYSICAL DEMAND While performing duties this job employee regularly required talk hear Employee frequently required stand walk use hands finger handle feel reach hands arms POSITION TYPEEXPECTED HOURS WORK This full-time position Monday Friday am pm additional hours business necessitate TRAVEL Occasional overseas domestic travel may required support rapid growth company Lincotek provides equal employment opportunity all individuals regardless race color creed religion gender age sexual orientation national origin disability veteran status any characteristic protected state federal local law Show more Show less
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