Site Quality Manager (m/f/d)

69115 Heidelberg, 69120 Heidelberg
04.03.2021

Daten dieser Anzeige

Job-ID: 020451496
Site Quality Manager (m/f/d)

Bausch & Lomb GmbH

Germany

Doris.Volkwein@bausch.com

Ensures that the Site Quality System is effective in meeting defined requirements and reports the performance to management as well as the compliance with applicable company, ISO, FDA and other regulatory and local policy requirements Leads and oversees all Quality and Compliance functions for the Heidelberg manufacturing site, incl. site Quality budget, Quality planning, Quality resources and development of Quality personnel Counterpart for notified body Ensures external / internal QMS audits and supplier audits are conducted on a scheduled basis and ensures the effectiveness of corrective and preventive action On-site expert on Quality and Compliance providing input and support for the Regional / Global Quality Strategies Areas of focus include, but not limited to Re-/Validation, Re-/Qualification, CAPA system, nonconformance management, supplier quality management, implementation of regional and global requirements

Naturwissenschaften Medizintechnik Gesundheit, soziale Dienste, Healthcare Wiley Leading and overseeing all Quality and Compliance functions for the Heidelberg manufacturing site Pharma, Chemie, Med., Biotechn. Ingenieurwesen Completed Degree in an Engineering or Natural Science 5 years medical device quality experience with EU MDD/MDR and US FDA Experience in communication with notified bodies and authorities Must possess at least an advanced level of performance in the majority of the following core competencies: influence key stake holders, business acumen, project management, relationship building, quality expertise Sound knowledge of the admission requirements according to MDD and MDR as well as DIN EN ISO 13485 Strong leadership skill Structured and thorough work attitude Advanced computing skills including Word, Excel, Outlook Email Excellent written and verbal communication skills in German and English Physik Qualitätswesen, Prüfung Art (Berufsfeld) Langjährige (> 7 J.) Deutsch Techn. Management, Projektplanung Ingenieur/Techniker Elektrotechnik Heidelberg Mehrjährige (3-7 J.) Direktor (Bereichsleiter, VP, SVP etc) Vollzeit Sonstige k.A. Baden-Württemberg Gesundheit und Soziales Site Quality Manager (m/f/d) Abitur Weitere Fachrichtungen Feinwerktechnik Pharmaindustrie Universitätsstudium Andere Berufsbereiche Industrie / Dienstleister Deutschland Mathe, Naturw., Umwelt Fachhochschulstudium Qualitätswesen, Zulassung 69115 anderes Studium Elektrotechnik, Energie-, Nachrichtent. Technische Berufe, Ingenieurwesen Technische Leitung Elektrotechnik, Feinmechanik, Optik Pharma und Medizintechnik Qualitätsmanagement Qualitätssicherung Qualitätsaudit Prüfverfahren Qualitätstechniker Qualitätskontrolle QM QM-Berater Lieferantenbetreuung QS Auditor Risikomanager Techniker technical techisch Qualitätsingenieur Qualitätsbeauftragter Heidelberg <69120> Gebiet (Branche) Bereichs-, Abteilungsleiter Elektrotechnik/Elektronik Ensures that the Site Quality System is effective in meeting defined requirements and reports the performance to management as well as the compliance with applicable company, ISO, FDA and other regulatory and local policy requirements Leads and oversees all Quality and Compliance functions for the Heidelberg manufacturing site, incl. site Quality budget, Quality planning, Quality resources and development of Quality personnel Counterpart for notified body Ensures external / internal QMS audits and supplier audits are conducted on a scheduled basis and ensures the effectiveness of corrective and preventive action On-site expert on Quality and Compliance providing input and support for the Regional / Global Quality Strategies Areas of focus include, but not limited to Re-/Validation, Re-/Qualification, CAPA system, nonconformance management, supplier quality management, implementation of regional and global requirements Handwerk, Fertigung, Inbetriebnahme Fertigung, Inbetriebn., Qualitätsw.

Technische Berufe/ Fertigung/ Produktion

Pharma, Chemie, Med.-/ Biotechnologie

Unternehmensführung/ Management

Ingenieurwesen

Projekt- und Produktmanagement/ Qualitätsmanagement

Chemie/ Pharma/ Biotechnologie

Elektronik/ Elektrotechnik/ Feinmechanik

Medizintechnik/ Optik

Gesundheits-/ Sozialwesen/ Medizin

Bereichs-/ Abteilungs-/ Gruppenleitung

Angestellter/ Fachkraft

Vollzeit

69115 Heidelberg

69120 Heidelberg