Quality Review Specialist

vor 6 Monaten

Aachen, Deutschland Johnson & Johnson Vollzeit

Abiomed ist ein innovatives Medizintechnik-Unternehmen mit einer inspirierenden Mission „Patients First.“ und einem einzigartigen Firmenmotto „Herzen regenerieren. Leben retten“. Mit mehr als 2.000 Mitarbeitern ist Abiomed eines der am schnellsten wachsenden Medizintechnik-Unternehmen weltweit mit dem Firmenhauptsitz in Danvers, USA sowie Standorte in Aachen und Berlin, Deutschland, Tokio, Japan und Singapur. Abiomed ist Teil von Johnson & Johnson MedTech.

Abiomed ist ein Arbeitgeber mit attraktiven Arbeitsbedingungen und einer wertschätzenden Unternehmenskultur, bei dem die Bedürfnisse der Mitarbeiter im Fokus stehen. Abiomed begeistert und bindet außerordentliche Talente durch Zusammenarbeit, Leidenschaft und kontinuierliche Weiterentwicklung.
- As _**_Quality Review Specialist_**_ _**/ **_Sachbearbeiter Qualitätssicherung _**(M/F/d) **you are responsible for providing QA on the floor oversight of manufacturing activities including observing manufacturing operations, performing in process inspection, and reviewing production documents such as device history record for partially assembled or finished medical devices documentation for compliance. You are also responsible for supporting resolution of potential non-conformance events by utilizing Quality Notification system in conjunction with other procedures as applicable.

**Principal Duties and Responsibilities**
- Perform Quality Reviews of Device History Records (DHR) on the production floor for GDP errors and ensuring completeness, accuracy of routine work as well as footnotes/ comments documented by Production staff. Advising production on proper documentation requirements as needed
- Perform inspection of critical manufacturing process steps to specified requirements such as in process inspections, clean room behavior and adherence to defined process parameters by performing walk-throughs of production and support areas.
- Conduct DHR review and release, including review of NCMR’s, QN’s and deviations etc.
- Ensure all personnel adhere to cGMPs at all times during the manufacture of medical device from assembly stage to finished medical device stage.
- Support production staff with resolution of potential nonconformance events by utilizing the QN system, in conjunction with other procedures as applicable, to facilitate decision-making with production, and other groups, as needed.
- Control and maintain current version of Device Master Documents on the production floor. Review, scan, maintain and archive Device History Records
- Participate in Internal and External Quality Audits and support the audit program as needed.
- Perform other duties as assigned.

**Qualifications**:
**Job Qualifications**
- Bachelor degree or commercial training (kaufmännische Ausbildung)
- Experience in medical device or pharmaceutical industry preferred
- Knowledge of ISO and GMP US FDA 21 CFR QSR 820 and ISO 13485
- Knowledge and or exposure of lean, kaizen, and continuous improvement initiatives
- Experience with SAP or other ERP system is a plus.
- Working knowledge of Microsoft Office Suite
- Good Communication skills in German and English
- Organized, detail-oriented, and able to prioritize responsibilities

**Wir bieten**:

- Angenehme, offene Unternehmenskultur mit einer starken Mission: "Recovering Hearts, Saving Lives"
- Umfassendes Einführungsprogramm mit strukturiertem Onboarding-Plan in der gesamten Orientierungsphase
- Zuschuss zur betrieblichen Altersvorsorge von bis zu 1.500, - Euro im Jahr und vermögenswirksame Leistungen
- Vorteilspakete für eine Berufsunfähigkeitsversicherung und eine betriebliche Gruppenunfallversicherung
- Komplette Kostenübernahme für ein Job Ticket im Raum Aachen oder Berlin
- Diverse Gesundheitsprogramme und Leasingmöglichkeit für ein Job-Rad

ABIOMED ist ein Arbeitgeber, der Chancengleichheit vertritt. Wir unterstützen die Chancengleichheit unserer Mitarbeiter ungeachtet der ethnischen Herkunft, der Hautfarbe, der Religion, des Geschlechts, der sexuellen Orientierung, der Geschlechtsidentität, einer Behinderung oder der Nationalität.

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