{"id":115,"date":"2015-10-26T18:03:12","date_gmt":"2015-10-26T17:03:12","guid":{"rendered":"http:\/\/thomasberger.eu\/public\/?p=115"},"modified":"2024-05-23T10:55:16","modified_gmt":"2024-05-23T09:55:16","slug":"operational-quality-engineer","status":"publish","type":"post","link":"https:\/\/www.thomasberger.eu\/?p=115","title":{"rendered":"2010 &#8211; 2015 &#8211; Operational Quality Engineer for Medical Devices"},"content":{"rendered":"\n<p>\u2022 Entreprise : PAUL HARTMAN S.A. Ch\u00e2tenois (France)<br>\u2022 Secteur : M\u00e9dical \/ Pharmaceutique<br>\u2022 P\u00e9riode : Juillet 2010 &#8211; Ao\u00fbt 2015<br>\u2022 Fonction :<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>&#8211; Chef de projet Assurance Qualit\u00e9<br>&#8211; Responsable des laboratoires de contr\u00f4le<br>&#8211; Ing\u00e9nieur qualit\u00e9 op\u00e9rationnel<br>&#8211; Responsable qualit\u00e9 fournisseur<\/p>\n<\/blockquote>\n\n\n\n<!--more-->\n\n\n\n<p>\u2022 R\u00e9alisations \/ Activit\u00e9s<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<ol>\n<li>Responsable op\u00e9rationnel des laboratoires de contr\u00f4le.\n<ul>\n<li>Management d\u2019\u00e9quipes et gestion des ressources (11 techniciens et agents de ma\u00eetrise), pilotage de proximit\u00e9 et d\u00e9marche Lean.<\/li>\n\n\n\n<li>Responsable de la m\u00e9trologie et d\u00e9veloppement du process dans la GPAO SAP PM<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Responsable relation qualit\u00e9 fournisseur.\n<ul>\n<li>Coordination et r\u00e9alisation des audits \u00e0 l\u2019international.<\/li>\n\n\n\n<li>Suivi, \u00e9valuation et accr\u00e9ditation des fournisseurs.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Charg\u00e9 d\u2019assurance qualit\u00e9 et de l\u2019am\u00e9lioration continue.\n<ul>\n<li>Pilotage du syst\u00e8me qualit\u00e9 : documentation, non-conformit\u00e9s, r\u00e9clamations, actions.<\/li>\n\n\n\n<li>Gestion des audits client et interne : ISO 13485, ISO 9001, GMP.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Charg\u00e9 de projet qualit\u00e9 pour le d\u00e9veloppement de nouveaux produits.\n<ul>\n<li>Gestion des validations et qualifications des processus et produits.<\/li>\n\n\n\n<li>R\u00e9ception et installation d\u2019\u00e9quipements en salle blanche, industrialisation (AMDEC produit et process, FAT, SAT, QI, QO, QP, validation pr\u00e9s\u00e9ries, essais industriels, \u2026).<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<\/blockquote>\n\n\n\n<p>\u2022 R\u00e9sultats<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<ul>\n<li>Aucune non-conformit\u00e9s majeures \u00e0 l\u2019audit T\u00dcV ISO 13485 et ISO 9001 de 2011 \u00e0 2015.<\/li>\n\n\n\n<li>Projet d\u2019installation des nouvelles lignes abouti : processus de production valid\u00e9s et produits commercialis\u00e9s en Aout 2015.<\/li>\n<\/ul>\n<\/blockquote>\n\n\n\n<p>\u2022 Description de l&rsquo;entreprise<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><a href=\"http:\/\/www.hartmann.fr\/portail\/li\/entreprise\/notre_groupe\/hartmann_france.htm\" target=\"_blank\" rel=\"noreferrer noopener\">http:\/\/www.hartmann.fr\/<\/a><\/p>\n\n\n\n<ul>\n<li>Industrie de grandes et moyennes s\u00e9ries ;<\/li>\n\n\n\n<li>Produits de n\u00e9goces m\u00e9dicaux<\/li>\n\n\n\n<li>Secteur m\u00e9dical, pharmaceutique et transport\/logistique de produits m\u00e9dicaux.<\/li>\n\n\n\n<li>Exemple pour l\u2019usine de S\u00e9lestat (68) : fabrication de changes et al\u00e8ses pour l\u2019incontinence (dispositif m\u00e9dical de classe 1), processus industriel. Thermoformage en salle blanche sur site (dispositif m\u00e9dical de classe 2a et 2b). Fabrication de pansements.<\/li>\n<\/ul>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>\u2022 Entreprise : PAUL HARTMAN S.A. Ch\u00e2tenois (France)\u2022 Secteur : M\u00e9dical \/ Pharmaceutique\u2022 P\u00e9riode : Juillet 2010 &#8211; Ao\u00fbt 2015\u2022 Fonction : &#8211; Chef de projet Assurance Qualit\u00e9&#8211; Responsable des laboratoires de contr\u00f4le&#8211; Ing\u00e9nieur qualit\u00e9 op\u00e9rationnel&#8211; Responsable qualit\u00e9 fournisseur<\/p>\n","protected":false},"author":1,"featured_media":38,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[127],"tags":[],"_links":{"self":[{"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=\/wp\/v2\/posts\/115"}],"collection":[{"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=115"}],"version-history":[{"count":1,"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=\/wp\/v2\/posts\/115\/revisions"}],"predecessor-version":[{"id":619,"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=\/wp\/v2\/posts\/115\/revisions\/619"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=\/wp\/v2\/media\/38"}],"wp:attachment":[{"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=115"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=115"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thomasberger.eu\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=115"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}