Quality Manager Medical Devices (m/f/d)

at  Fresenius Kabi

As Quality Manager you will act as Deputy for the Head of Quality Compounding Devices (Quality Management Representative) and report to him. In this role you will ensure compliance in Development Projects incl. Risk Management.
Further responsibilities:

• Quality Approver for Events, Complaints, CAPAs and Change Controls
• Execution of Incoming Goods Inspection and preparation of batch & device release documentation
• Preparation, monitoring and support of audits and inspections (internal and external)
• Collection and Preparation of Quality Key Performance Indicators
• Review, Update and (if necessary) Approval of SOPs and WIs incl. Training
• Support or execute investigations / Root Cause Analysis and related definition of actions
• Support Risk Management activities, Qualifications & Validations and Supplier Quality Management

Your profile

• Graduate degree in engineering in the field of electrical engineering, mechanical engineering, medical technology or similar
• Several years of experience in Medical Device Industry (R&D, Manufacturing, Quality Control), Supplier Quality Management and Quality Assurance
• Very good knowledge of ISO 13485, ISO 9001 and ISO 14971
• Founded knowledge of the GMP regulations and the regulation 21 CFR Part 820
• Experience with TrackWise (Sparta System) and Auditing (certification as Lead Auditor is a plus)
• Fluent English and German, both written and spoken
• Structured, pragmatic and self-reliant way of working

Auf einen Blick
Standort:
HessenBad Homburg
Karrierelevel:
Berufserfahrene
Einsatzbereich:
IngenieurwesenQualitätsmanagement / Umwelt
Arbeitsverhältnis:
UnbefristetVollzeit
Unternehmen:
Fresenius Kabi
Referenznummer:
59186
Veröffentlicht am:
20.03.2024
Solange die Stellenanzeige online ist, können Sie sich schnell und einfach bewerben

Please refer the Job description for details