/ CAREER WITH A PURPOSE /
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.
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.
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
At a glance
Career level:
Professional Experienced
Job category:
Engineering, Quality Management / Environment
Working condition:
Temporary / Full-time
Business segment:
Fresenius Kabi
Location:
Bad Homburg / Hessen
Closing date for applications:
none - we look forward to your application
Your contact
- Sandra Raickovic
- Fresenius Kabi Deutschland GmbH
- Bad Homburg
- Ref. number: 59186
About Fresenius
Career with a purpose:
Over 300,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
career.fresenius.com fresenius.com
One of Fresenius' strengths:
our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.
The benefits we offer:
Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.
Your contact
- Sandra Raickovic
- Fresenius Kabi Deutschland GmbH
- Bad Homburg
- Ref. number: 59186
Professional Experienced
Job category:Engineering, Quality Management / Environment
Working condition:Temporary / Full-time
Fresenius Kabi
Location:Bad Homburg / Hessen
Closing date for applications:none - we look forward to your application
About Fresenius
Over 300,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
career.fresenius.com
fresenius.com
One of Fresenius' strengths:
our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.
More reasonsThe benefits we offer:
Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.
More benefits