Sie sind hier: Home > Regional > !#platzhalterstadtname!# >

!#platzhalterdienstname!#

Anzeige
Filter

Qualitätsmanagement: 3 Jobs in Eurasburg bei Wolfratshausen

Berufsfeld
  • Qualitätsmanagement
Branche
  • Medizintechnik 2
  • Elektrotechnik 1
  • Feinmechanik & Optik 1
Berufserfahrung
  • Mit Berufserfahrung 3
  • Ohne Berufserfahrung 1
Arbeitszeit
  • Vollzeit 3
Anstellungsart
  • Feste Anstellung 3
Qualitätsmanagement

Quality Manager (f/m/d) Medical Device Reporting Officer (MDRO) / Qualitätsmanager (m/w/d)

Sa. 08.08.2020
Weßling
Dornier MedTech, a wholly-owned subsidiary of Advanced MedTech Holdings Pte. Ltd., is an innovative market leader in urology. As the pioneer of shockwave lithotripsy and a variety of surgical lasers for transcutaneous, endoscopic and laparoscopic applications, Dornier continues to develop advanced medical solutions for the urology market. The company offers a complete portfolio of active and non-active medical devices for stone and BPH treatment including lithotripters, lasers, imaging systems, tables and consumables. Dornier also offers shock wave treatment devices for a variety of urological and orthopedic applications. As a global company, Dornier has operating units and service partners throughout the world. Dornier MedTech is a privately held company headquartered in Weßling near Munich, Germany. We are looking for a Quality Manager (f/m/d) Medical Device Reporting Officer (MDRO)  Responsible for reporting obligations, as far as they concern medical product risks (§30 MPG / Art. 15 MDD) Work with all relevant departments to ensure appropriate and timely actions like corrective actions and preventive actions are implemented Make sure that all necessary measures in the course of the reporting system are implemented on time Deliver results as measured by key metrics, such as on time proceeding and corrective & preventative action closure Work with Engineering (Design and Manufacturing Engineers) team to close complaints in a high quality and timely manner Check documentation in course of working on complaints / (reportable) events and initiate counter actions internally as well as at the necessary departments Perform high quality and traceable documentation on event, CAPA and complaint proceeding Establish on eye level communication with authorities worldwide Follow up on internal and supplier audits, and support process owners and adjacent stakeholders to close all emerged deviations in due time Support in planning and conducting internal as well as supplier audits Study graduation in any field Proven knowledge in terms of CAPA and Complaint Management Relevant experience in reporting to regulatory authorities (like BfArM, TÜV, FDA, ...) Understanding for deadlines and an ability to work under pressure Proficiency with MS Office (Word, Excel, Project etc.) Proficient experience within QMS (ISO13485 / MDD / MDR) – at least 5 years Be able to function independently of direct supervision Analytic ability to assess and identify appropriate alternative courses of action for definition and resolution of problems that are somewhat unique and diverse Drive “Zero Defect” mentality within the department Excellent oral English with very good English writing skills Personalized onboarding plan with an experienced buddy Opportunities for promotion based on performance Diversified assignments in a dynamic environment Continuous training and development Flat hierarchy Flexible working hours 30 days of vacation Appealing canteen Free coffee, tea and water Employee engagement events Electric car charging stations
Zum Stellenangebot

Mitarbeiter Qualitätssicherung - Retourenbearbeitung (m/w/d)

Sa. 01.08.2020
Germering
Die Distec GmbH gehört zur börsennotierten FORTEC Group, einer deutschen, international tätigen Firmengruppe mit Tochterunternehmen in Deutschland, den USA, der Schweiz und in England mit über 200 Mitarbeitenden.Als Lösungsanbieter für industrielle Datenvisualisierung entwickeln und fertigen wir neben der Distribution kundenspezifische Lösungen. Unsere Kunden sind unter anderem in der Automatisierung, der Medizintechnik, der Mess- und Regeltechnik oder der Luftfahrt zu Hause.  Wir brauchen Menschen, die Ideen zu Innovationen machen! Zur Verstärkung unseres Qualitätsmanagement-Teams in Germering bei München suchen wir zum nächstmöglichen Zeitpunkt eine*nMitarbeiter Qualitätssicherung - Retourenbearbeitung (m/w/d).Erfassung, Bewertung, Nachverfolgung und Ablage von Retouren / Reklamationen (Kunde, Lieferant) in SAP Wareneingangsprüfung von Waren mit gängigen Messmitteln  Kommunikation mit Kunden und LieferantenDefinieren von Abstellmaßnahmen bei festgestellten Abweichungen mit den jeweiligen Fachabteilungen sowie entsprechende Überwachung der Maßnahmen  Bereitstellen von Informationen für die entsprechenden Fachabteilungen bzgl. der Retouren / Reklamationen  Erstellung, Pflege und Verwaltung von relevanter dokumentierter Information zur Sicherstellung der Qualitätssicherungsanforderungen  Unterstützung bei der Pflege und Weiterentwicklung des QualitätsmanagementsystemsUnterstützung bei der Auswertung von Qualitätsdaten und QualitätskennzahlenAbgeschlossene technische Berufsausbildung oder eine vergleichbare QualifikationBerufserfahrung in der Qualitätssicherung oder im Vertrieb Innendienst wünschenswertSicherer Umgang mit MS-Office ProduktenGute Kenntnisse beim Lesen von technischen Zeichnungen und Erstellen / Vorbereiten von 8D-Berichten Erfahrung mit SAP von VorteilSicheres Englisch in Wort und SchriftSelbstständiges, zuverlässiges und verantwortungsbewusstes Arbeiten Souveränes und freundliches Auftreten gegenüber Kunden und LieferantenEin innovatives mittelständisches Unternehmen mit internationaler Ausrichtung und flachen HierarchienEin angenehmes, kollegiales und wertschätzendes Klima mit kurzen EntscheidungswegenSie haben Gestaltungsspielraum und die Möglichkeit eigene Ideen einzubringenFort- und Weiterbildungsmöglichkeiten sowie gute betriebliche SozialleistungenEin modernes Arbeitsplatzkonzept mit aktueller IT-AusstattungKostenlose Getränke, Küche, klimatisierte Büroräume, Ladestationen für E-Mobility sowie Duschen für (E-)Biker*innenSie erhalten eine gründliche EinarbeitungEs erwartet Sie eine attraktive VergütungSie haben vielseitige Möglichkeiten sich im Unternehmen stetig weiterzuentwickeln
Zum Stellenangebot

Development Engineer (m/f/d) Electric / Entwicklungsingenieur (m/w/d) Elektronik

So. 26.07.2020
Weßling
Dornier MedTech, a wholly-owned subsidiary of Advanced MedTech Holdings Pte. Ltd., is an innovative market leader in urology. As the pioneer of shockwave lithotripsy and a variety of surgical lasers for transcutaneous, endoscopic and laparoscopic applications, Dornier continues to develop advanced medical solutions for the urology market. The company offers a complete portfolio of active and non-active medical devices for stone and BPH treatment including lithotripters, lasers, imaging systems, tables and consumables. Dornier also offers shock wave treatment devices for a variety of urological and orthopedic applications. As a global company, Dornier has operating units and service partners throughout the world. Dornier MedTech is a privately held company headquartered in Weßling near Munich, Germany. We are looking for a Development Engineer (m/f/d) Electric In this role you will develop, implement and test electrical and electronic components and systems for medical devices. You will focus on delivering innovative solutions, which meet customer as well as regulatory requirements, particularly those related to safety and effectiveness. Collect and analyze technical requirements and follow through with the subsequent development and implementation, including product design, cost reduction, new products and components to series production level, and test protocols for testing of components and systems Create control concepts as well as electrical and system safety concepts to assure functional safety Design wiring concept of the system and interconnecting devices Create component and system specifications and other quality related documents such as risk analysis, test and verification reports in compliance with international requirements (CE, FDA, MHLW, others) Maintain products to ensure stable and reliable operations as part of product lifecycle management Monitor industry trends on electrical, electronic and mechatronic engineering, including competitors’ technologies Provide technical and troubleshooting support on electrical issues to other departments if needed Coordinate and work with third-party supplier or other contractors Coordinate and support compliance activity (EMC, Safety, others) Master’s degree in engineering, preferably with specialization in electrical, electronics, mechatronics or biomedical engineering More than 5 years of experience in electrical engineering / development experience within the medical device or related sector Experience in digital, analog, advanced microprocessor and microcontroller technology based design Experienced in integration of wireless module such as WiFi, Bluetooth and GSM into hardware Experienced in complex PCB design, in development of PLC- and PC-controlled systems and in design and development of cable harness of complex systems Experience in power electronics including motor control, power supply and transformer design Knowledge in ISO 13485, IEC 14971, IEC 60601-1 and IEC 60601-1-2 will be advantageous Experience in product compliance related to EMC and Safety Experienced in creating technical reference documentation Preferably experience in risk analysis, requirement management and systems engineering Fluent in English and German, both oral and written Personalized onboarding plan with an experienced buddy Continuous training and development Flat hierarchy Flexible working hours 30 days of vacation Appealing canteen
Zum Stellenangebot


shopping-portal