.header-table table, .header-table img { width:100%; } .header-table { } div.formSectionBody { padding: 0px !important; } .joqReqDescription { text-align: left; max-width: 1500px; min-width: 930px; background-color: #FFFFFF; line-height: 20px; } div.joqReqDescription .centerJob .h1 { font-family: Arial, Helvetica, sans-serif; font-weight: bold; font-size: 28px; line-height: 32px; color: #8c8c8c; text-align: left; padding: 25px 0px 15px 0px; border:none; } div.joqReqDescription .centerJob .h2 { font-family: Arial, Helvetica, sans-serif; font-weight: normal; font-size: 20px; line-height: 24px; margin: 7px 0px 0px 0px; color: #8c8c8c !important; } div.joqReqDescription .centerJob .h3, div.joqReqDescription .centerJob .h3 span, div.joqReqDescription .centerJob .h4, div.joqReqDescription .centerJob .h4 span { font-family: Arial, Helvetica, sans-serif !important; font-weight: normal; font-size: 18px !important; line-height: 24px; margin:0px; color: #8c8c8c !important; padding: 0px; } .centerJob .h4 { } .centerJob .gab, .centerJob .gab1 { display: block; width: 100%; height: 20px; } .centerJob .gab1 { height: 13px; } div.joqReqDescription ul, div.joqReqDescription ol{ margin: 0px; padding-left: 15px; margin-left: 30px; } div.joqReqDescription ul li, div.joqReqDescription ol li{ list-style-type: square; background: transparent; margin: 0px; padding: 0px 0px 2px 0px; color: #8c8c8c; } div.joqReqDescription span, div.joqReqDescription p, div.joqReqDescription font, div.joqReqDescription ul li, div.joqReqDescription ol li { color: #8c8c8c !important; font-size: 15px !important; text-align: left !important; font-family: "Trebuchet MS",Arial,Verdana,sans-serif !important; } div.joqReqDescription p em { font-style:normal !important; } div.joqReqDescription p u { text-decoration:none !important; } .joqReqDescription .footer { padding-top: 13px; } .joqReqDescription a, .joqReqDescription a:hover, .joqReqDescription a:visited, .joqReqDescription a:active { color:black; font-weight: bold; color: #8c8c8c; } .joqReqDescription .padding { padding: 0px 30px; } .joqReqDescription p { padding: 0px 30px; } .joqReqDescription div p { padding: 0px; }Quality Systems SpecialistHeraeus MedevioLocation CartagoPermanentFull Time

JOB PURPOSE

Work in the coordination of document control (DCRs, CCIDs, CAPAS), Induction training in good documentation practices (GDPs) I also prepare presentations for management review and sterilization release

Provide support in external audits and support in the needs of the area. Review and approve the corresponding responsibilities to ensure that priorities are met in a correct and timely manner.

MAJOR RESPONSIBILITIES

The following information state the main responsibilities of the position but are not limited to. By the other side it is important to indicate that time percentage will vary according to the business needs:

Register or modify the documents in the system to comply with global and local requirements.Keep updated the change control and CCIDs to have the quality management system in complianceProvide CAPA tasks to the owner of process to ensure that the investigation report is completed and that the root cause has the instructions and actions should be reviewed.Oversight the sterilization release to manage handling according to the quality procedures.Lead the external audits assuring the compliance QMS vs International Standards included but not limited to ISO:13485for compliance with customer requirements or legality for the manufacture of medical devices.Provide technical information about the current requirements that must be applied in the quality area in alignment with ISO 13485 and EN BS 171415.Realize the new personnel training in compliance with ISO 13485 assuring good documentation practices (GDPs)

Education                        

Bachelor's degree/advanced studies with a major in Engineering or related field.

Knowledge and skills

High level of knowledge on validationsProficient in using CAQ and SAPSpoken and written business EnglishKnowledge of CAPAKnowledge of AuditsKnowledge of good documentation practicesKnowledge of CFR 21Knowledge of ISO 13485Knowledge of Sterilization

Experience      

0-3 Years of experience as Doc ControlExternal Audit.joqReqDescription .float-right { position: relative; right: 0px; bottom: 40px; float: right; } .joqReqDescription .float-left { float: left; margin-top: 15px !important; } .openmind { width:300px; } .badge { height: 80px; }.ex_footer { height: 140px; }.logos_hpm_bottum img{ max-height: 140px; padding: 20px; display: inline-block; vertical-align: middle; }.logos_hpm_bottum{ height:140px; margin-bottom: 35px;}

Curious? Apply now!

We are interested in finding the best candidates, and they may come from a nontraditional background. So please don’t hesitate to apply, even if you aren’t an exact fit. We look forward to getting you started on your employment journey with Heraeus Medevio!

Any further questions?

Our Recruiting Team, Heraeus Medevio, is happy to assist you by email: jobs-medevio@heraeus.com. Or visit us at jobs.heraeus.com.

ReqID: 58075