Job Lead Medical Device (m/f) unspecified siehe Beschreibung - Jobangebote

Berufsbezeichnung: Lead Medical Device (m/f)

Arbeitsbeschreibung:
Werden Sie ein Teil von uns. Zusammen können wir neue Wege finden, um Menschen zu einem besseren und längeren Leben zu verhelfen. Als Teil der weltweiten Novartis Gruppe sind wir an den Standorten Kundl und Schaftenau auf die Entwicklung und Produktion von Antibiotika und Biologika spezialisiert.

1 Lead Medical Device (m/f)

STELLENBESCHREIBUNG:

The Lead Medical Device for the Medical Device Unit Schaftenau bei Kufstein / Tirol is accountable for the quality oversight of activities associated with technical development, commercialization, and manufacture including Life Cycle Management of medical devices used for biologics or combination products under responsibility of the Medical Device Unit in Schaftenau. The incumbent will ensures the reliable supply of medical devices for strategic Novartis Biologic and Biosimilar product portfolio (including Omnitrope, Zarzio, and Delta etc.). He/She will lead a team of Quality Managers/Experts/Specialist to ensure technical development and manufacturing operations of Medical Devices are conducted in accordance with Novartis Quality System requirements, ensuring high product quality, regulatory compliance and operational efficiency. He/She will be the Medical Device Management representative according to ISO 13485 and the delegated person for safety regarding Austrian medical device law (MPG) § 78; In this role he/she will be the contact person for Notified Body and responsible to assure a successful notify body certification; He/She is responsible to lead and manage the assigned Team members.

o Coordination, participation and follow up of Audits and Inspections of "Notified bodies", authority inspections and internal / external audits and other regulatory bodies e.g. FDA. Accountable for a successful outcome of regulatory inspections in regard to medical device compliance..

o Development and revision of QA Agreements and Service Level Agreements of suppliers, third parties and service providers.

o Coordination and evaluation of claims as well as notification of authorities in case of notifiable incidents or Field Safety Corrective Actions (FAs, MDRs) and related intercompany escalations.

o Coordination and development of Post Market Surveillance

Reports;

o Accountable for the release of medical devices.

o Investigation and mitigation of medical device related product issues like complaints, adverse event reports and general product issues in regard to medical devices (MD) and combination products for the MD as constituent part.

o Accountable for the implementation and maintenance of all required Medical Device Certifications and Management Reviews for all product and combination products manufactured with cGMP, legal & regulatory requirements and the Novartis Pharma Corporate Quality Manual.

o Lead, actively engage in and support assigned quality

MINIMUM REQUIREMENTS:

Education: MSc in Pharmacy, Biotechnology, Chemistry, Biology, Physics, Chemical engineering or related or similar

Languages: Fluent level of English, German/French beneficial

We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least €48.718,04 per year)

Division: Novartis Technical Operations

Geschäftseinheit: NTO QUALITY

Land: Österreich

Standort: Schaftenau bei Kufstein / Tirol

Wir freuen uns über Ihre vollständigen und aussagekräftigen Bewerbungsunterlagen über das BrassRing Novartis Recruiting System unter www.novartis.at/karriere (Job ID: 243754BR )

Das Mindestentgelt für die Stelle als Lead Medical Device (m/

Wie Sie sich bewerben: Schriftliche Bewerbung, online

Vertragstyp: contracttohire

Angestelltenname: siehe Beschreibung